Sophic Logo gordian knotColorectal Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in March 2026


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1: Summary data from new trials identified for Colorectal Cancer.


Overview

Number of Trials: 21

These 21 trials span diverse oncology indications including colorectal, breast, ovarian, pancreatic, gastric, and anal cancers, as well as familial adenomatous polyposis (FAP). Interventions range from novel biologics (e.g., EP2/EP4 antagonist TPST-1495, PD-1 inhibitors retifanlimab and toripalimab, bispecific antibody INCA33890, ADC ASP546C) to behavioral and supportive care approaches (exercise therapy, time-restricted eating, dietary modification, health coaching). Several trials focus on precision medicine using ctDNA, genomic biomarkers, or mass-based response testing to guide treatment. Others evaluate surgical techniques (uteroovarian transposition, PIPAC), imaging agents (68Ga-labeled tracers), and symptom management (vaginal DHEA, retrograde enema). The trials emphasize personalized treatment, early detection, prevention, and quality of life improvements.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years
  • ECOG performance status 0-2
  • Histologically or cytologically confirmed malignancy
  • Adequate organ and marrow function (ANC, platelets, hemoglobin, liver enzymes, creatinine within specified limits)
  • Measurable or evaluable disease per RECIST v1.1
  • Ability to understand and sign informed consent
  • Willingness to comply with study procedures and follow-up
  • Use of effective contraception for women of childbearing potential and men

Common Exclusion

  • Pregnant or breastfeeding
  • Active uncontrolled infection
  • Uncontrolled intercurrent illness or psychiatric conditions limiting compliance
  • Known brain metastases (unless stable and treated)
  • History of other malignancy within 2-5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ)
  • Active autoimmune disease requiring systemic treatment
  • Known HIV, hepatitis B, or hepatitis C infection (unless controlled/undetectable viral load)
  • Prior treatment with investigational agents within specified timeframe
  • Severe cardiac disease (myocardial infarction, unstable angina, congestive heart failure within 6 months)
  • Hypersensitivity to study drugs or excipients

Outcomes Summary

Primary Outcomes

Secondary Outcomes


2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT06557733

Phase 2 Study to Evaluate the Efficacy and Safety of TPST-1495 in Patients With Familial Adenomatous Polyposis (FAP) Genomic-based

Organization/Sponsor: National Cancer Institute (NCI)


Example patient: A 32-year-old with confirmed APC mutation and Spigelman stage 2 duodenal polyposis who underwent prophylactic colectomy with IPAA 18 months ago, has ECOG status 0, and is H. pylori negative.

Phase 2

Interventions

  • Drug: EP2/EP4 Antagonist TPST-1495
    Summary: Orally bioavailable dual antagonist of prostaglandin E2 receptors EP2 and EP4 that blocks PGE2-mediated immune suppression and tumor cell proliferation in the tumor microenvironment by preventing activation of immunosuppressive pathways and restoring anti-tumor immune function (NCI Thesaurus).
  • Procedure: Esophagogastroduodenoscopy
    Summary: Endoscopic examination of the esophagus, stomach, and duodenum used to assess duodenal polyposis stage and monitor disease progression in FAP patients (Summary of Web Search).
  • Procedure: Gastrointestinal Endoscopy
    Summary: Endoscopic visualization of the gastrointestinal tract used for diagnosis, staging, and monitoring of polyposis burden (NCI Thesaurus).
  • Procedure: Biopsy Procedure
    Summary: Removal of tissue specimens for microscopic examination to establish diagnosis and assess dysplasia or malignancy in polyps (NCI Thesaurus).
  • Other: Biospecimen Collection
    Summary: Gathering of tissue and fluid samples for research analysis to understand disease mechanisms and treatment effects (NCI Thesaurus).
  • Other: Questionnaire Administration
    Summary: Collection of patient self-reported outcomes to assess quality of life and subjective treatment experiences (NCI Thesaurus).

Key Inclusion

  • Diagnosis of FAP with confirmed APC mutation or clinical criteria with ≥100 colorectal adenomas
  • Prior prophylactic colectomy or sub-total colectomy at least 12 months before enrollment
  • Spigelman stage 2 or 3 duodenal polyposis
  • Age ≥18 years
  • ECOG performance status ≤2
  • Adequate hematologic, hepatic, and renal function
  • H. pylori negative or successfully treated with confirmed eradication
  • Willing to discontinue NSAIDs 5 days prior to treatment and limit use during study

Key Exclusion

  • Use of investigational agents ≤12 weeks prior to enrollment
  • History of invasive malignancy ≤3 years prior
  • High grade dysplasia or cancer, GI bleeding, or need for anticoagulation
  • Strong or moderate inhibitors of CYP2D6 and CYP3A4
  • HIV, chronic HBV or HCV infection even if viral load undetectable
  • Active or refractory H. pylori infection
  • Prior history of peptic ulcers with bleeding or NYHA Class II-IV heart disease
  • Upper GI surgery preventing evaluation of 10 cm duodenal segment

NCT07425054

ctHPVDNA Adapted ChemoRadiation +/- Retifanlimab Treatment in Locally-Advanced Anal Cancer (CHART-AC) Genomic-based

Organization/Sponsor: Case Comprehensive Cancer Center


Example patient: A 52-year-old with stage T3N1M0 anal canal squamous cell carcinoma, ECOG status 1, no prior chemotherapy or pelvic radiation, adequate organ function, and negative for DPYD deficiency.

Phase N/A

Interventions

  • Biological: Retifanlimab
    Summary: A PD-1 blocking monoclonal antibody that enhances anti-tumor immune responses by inhibiting programmed death receptor-1, indicated for squamous cell carcinoma of the anal canal in combination with chemotherapy or as monotherapy (FDA label, NCI Thesaurus).
  • Drug: Chemotherapy
    Summary: Synthetic or naturally-occurring chemicals that target rapidly dividing cancer cells by interfering with cell division through mechanisms including DNA damage and inhibition of cell proliferation (NCI Thesaurus).
  • Radiation: HPV ctDNA Response based radiation
    Summary: Radiation therapy adapted based on circulating tumor HPV DNA levels to detect minimal residual disease and tailor treatment intensity, optimizing efficacy while minimizing side effects (Summary of Web Search).

Key Inclusion

  • Stage T1-4N+M0 or T3-T4N0M0 anal canal or anal margin squamous cell carcinoma
  • Age ≥18 years
  • ECOG performance status 0-2
  • Creatinine clearance >30 ml/min
  • HIV-infected participants eligible if CD4 ≥200/mm3 and viral load <200 copies/mm3
  • No prior chemotherapy for anal cancer
  • No prior potentially curative surgery (APR) for anal cancer
  • Adequate organ and marrow function (hemoglobin ≥10.0 g/dl, ANC ≥1,500/mcL, platelets ≥100,000/mcL)

Key Exclusion

  • Any prior pelvic radiation or overlapping radiation fields
  • History of allergic reactions to capecitabine or similar compounds
  • Active autoimmune disease or inflammatory bowel disease requiring systemic treatment in past 2 years
  • Prior treatment with immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-CTLA4)
  • Immunodeficiency or systemic steroid therapy >10 mg prednisone daily within 7 days
  • Live vaccines within 30 days prior to first dose
  • Known homozygosity for DPYD deficiency
  • Fistula between tumor and invaded organ

NCT07304063

Let's Talk: Overcoming Barriers to Uptake of Cascade Screening Through a Stakeholder-informed Online Intervention Genomic-based

Organization/Sponsor: UNC Lineberger Comprehensive Cancer Center


Example patient: A 45-year-old adult with self-reported Lynch syndrome who has not yet informed all family members about the hereditary cancer diagnosis and is willing to participate in an online communication intervention.

Phase N/A

Interventions

  • Behavioral: Let's Talk Patients
    Summary: Patient support intervention targeting education and communication to improve adherence and family notification about Lynch syndrome diagnosis (Source: Web Search).
  • Behavioral: Let's Talk Genetics Providers
    Summary: Genetic counseling intervention focusing on hereditary risk factors and genetic testing to facilitate cascade screening for Lynch syndrome families (Source: Web Search).

Key Inclusion

  • Age ≥ 18 years
  • Self-reported Lynch syndrome diagnosis
  • Written informed consent obtained
  • Willing and able to comply with study procedures
  • Genetic counselor employed at medical institution (for counselor arm)

Key Exclusion

  • Patient has already notified all relatives about Lynch syndrome diagnosis
  • Genetic counselor is not employed (for counselor arm)

NCT07291180

A Feasibility Study of Mass-Based Response Drug Screening to Guide Personalized Hyperthermic Intraperitoneal Chemotherapy for High-Grade Appendiceal and Colorectal Adenocarcinoma With Peritoneal Metastasis Genomic-based

Organization/Sponsor: Yale University


Example patient: A 62-year-old with ECOG status 1, unresectable colorectal adenocarcinoma with peritoneal metastases (PCI 22), stable liver lesions, adequate organ function, and no prior intraperitoneal therapy.

Phase N/A

Interventions

  • Diagnostic Test: Mass-based response testing (MRT)
    Summary: Mass-based response testing analyzes tumor mass for molecular markers to guide personalized hyperthermic intraperitoneal chemotherapy selection in colorectal and appendiceal cancers with peritoneal metastases. Source: Web Search.

Key Inclusion

  • Histologically confirmed peritoneal metastases from appendiceal or colorectal adenocarcinoma, AJCC Stage IV
  • Unresectable disease or PCI >19
  • Limited or stable extraperitoneal metastases
  • Age 18-80 years
  • ECOG performance status 0-2
  • Expected survival >3 months
  • Adequate organ function
  • Creatinine clearance ≥60 mL/m²

Key Exclusion

  • Known significant extraperitoneal metastasis
  • Hypoxia (pulse oximeter <92%) or requires supplemental oxygen
  • Creatinine clearance <60 mL/m²
  • Clinically significant cardiac disease or NYHA Class III/IV heart failure
  • Moderate to severe hepatic impairment (Child-Pugh B or C)
  • Prior radiation, ablative procedures, or cytoreductive surgery within 3 months
  • Previous iterative intraperitoneal therapy
  • Progressive disease after first 3 months of systemic chemotherapy

NCT07277322

Master Protocol for A Phase 1b/2 Study of Neoadjuvant Immunotherapy in Microsatellite Stable (MSS) Colorectal Cancer (CRC) Subjects With Resectable Liver Metastases Genomic-based

Organization/Sponsor: Icahn School of Medicine at Mount Sinai


Example patient: A 52-year-old with ECOG 0, non-MSI-H/pMMR colon cancer and synchronous resectable liver metastases, treatment-naïve, adequate organ function, no autoimmune disease, and willing to use contraception.

Phase 1b, Phase 2

Interventions

  • BLA: Toripalimab
    Summary: Toripalimab is a PD-1 inhibitor that enhances immune response against cancer cells by blocking PD-1, tested in combination therapies for colorectal cancer including MSS subtypes (Source: Web Search).
  • BLA: Dupilumab
    Summary: Dupilumab targets IL-4 and IL-13 pathways, primarily approved for asthma and atopic conditions, being investigated in this trial for potential immunomodulatory effects in MSS colorectal cancer (Source: Web Search).

Key Inclusion

  • Histological diagnosis of non-MSI-H/pMMR CRC
  • Resectable liver metastases (synchronous or metachronous)
  • Surgical candidate for resection
  • Age ≥18 years
  • ECOG Performance Status 0-1
  • Adequate organ and marrow function
  • Women of child-bearing potential must use contraception
  • Metachronous metastasis with adjuvant chemotherapy completed >3 months prior

Key Exclusion

  • History of autoimmune disorder requiring systemic treatment
  • Prior treatment with dupilumab within 8 weeks
  • Chemotherapy or locoregional therapy within 3 months
  • Extrahepatic metastases not amenable to resection
  • Active infection requiring antibiotics
  • Pregnant or nursing women
  • Systemic immunosuppressive therapy within 7 days
  • HIV positive with detectable viral load or CD4+ <200 cells/microliter

NCT07345676

Optimizing Evidence-Based Interventions to Improve Colorectal Cancer Screening Adherence in Community Health Clinics

Organization/Sponsor: Yale University


Example patient: A 58-year-old established patient at Cornell Scott Hill Health with a positive FIT test from 120 days ago who has not completed the recommended follow-up colonoscopy.

Phase N/A

Interventions

  • Behavioral: Bundled messaging intervention
    Summary: A behavioral intervention designed to alter patient behavior and improve colorectal cancer screening adherence through messaging strategies; intended to have preventive effects in the target population (source: NCI Thesaurus).

Key Inclusion

  • Established adult medicine patient at Cornell Scott Hill Health
  • Having a CSHH primary care doctor or >1 adult medicine visits in the last year
  • Incomplete colorectal cancer screening test with outstanding order for colonoscopy or stool-based CRC screening
  • Orders placed between 90-180 days prior to randomization
  • Abnormal stool-based test (positive FIT or FIT-DNA) without follow-up
  • No completed diagnostic colonoscopy within 90 days of abnormal result

Key Exclusion

  • No exclusion criteria beyond inclusion requirements

NCT06258525

A Phase II, Open-Label Trial of S-Adenosylmethionine (SAMe) in Prevention of Oxaliplatin Associated Liver Injury

Organization/Sponsor: Cedars-Sinai Medical Center


Example patient: A 62-year-old man with newly diagnosed Stage IV colorectal cancer with resectable liver metastases, ECOG 1, no prior chemotherapy for metastatic disease, and no neuropathy, referred for oxaliplatin-based chemotherapy followed by liver resection.

Phase II

Interventions

  • Procedure: Surgery
    Summary: Surgery for colorectal cancer involves physical excision of cancerous tumors and surrounding tissue to eliminate malignant cells, often used in combination with other treatments (Summary of Web Search).
  • Dietary Supplement: S-adenosylmethionine (SAMe) supplement
    Summary: SAMe inhibits colon cancer progression, induces senescence, enhances chemotherapy efficacy, reduces inflammation, supports DNA repair, and inhibits P-glycoprotein to improve drug sensitivity (Summary of Web Search).
  • Drug: Standard of care oxaliplatin-based chemotherapy
    Summary: Oxaliplatin-based chemotherapy causes DNA damage in cancer cells leading to cell death, primarily for colorectal cancer, often combined with fluorouracil and leucovorin; side effects include neuropathy and myelosuppression (Summary of Web Search).

Key Inclusion

  • Stage IV resectable liver predominant metastatic colorectal cancer
  • Age ≥18 years
  • Planning liver resection following oxaliplatin-based chemotherapy
  • ECOG Performance Status 0-2 or KPS ≥60%
  • Adequate organ and marrow function
  • Negative pregnancy test for females of childbearing potential
  • Stable vitamin E dose if taking ≥800 IU/day
  • Stable anti-diabetic medication dose for 90 days

Key Exclusion

  • Previously received chemotherapy for metastatic disease within 6 months
  • Pre-existing grade ≥3 neuropathy
  • Known additional progressing malignancy
  • Hypersensitivity to SAMe, oxaliplatin, fluorouracil, folinic acid, or capecitabine
  • Pregnant or breastfeeding
  • History of cirrhosis, Hepatitis A/B/C, NAFLD, or liver transplantation
  • History of Parkinson's disease or bipolar disorder
  • Taking MAO inhibitors or olanzapine

NCT07419490

A Phase I Assessment of Utero-ovarian Transposition (UOT) for Fertility Preservation in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy (WPXRT)

Organization/Sponsor: University of South Florida


Example patient: A 32-year-old woman with newly diagnosed rectal cancer requiring pelvic radiotherapy, BMI 28, normal ovarian function (FSH 7 IU/L, AMH 2.5 ng/mL), no metastases, desiring future pregnancy.

Phase 1

Interventions

  • Procedure: Uteroovarian transposition
    Summary: A surgical procedure to relocate the uterus and ovaries outside the radiation field to preserve fertility in patients requiring pelvic radiotherapy (NCI Thesaurus).

Key Inclusion

  • Women 18-40 years of age who wish to preserve fertility
  • Diagnosis of pelvic malignancies requiring radiotherapy (colon, rectal, anal, or other pelvic cancers)
  • Normal ovarian function (FSH <10 IU/L, AMH >1 ng/mL)
  • No distant metastasis confirmed by imaging
  • BMI <35

Key Exclusion

  • Advanced cancer stage or metastatic disease
  • Prior pelvic radiotherapy
  • Poor ovarian reserve (FSH >10 IU/L, AMH <1 ng/mL)
  • Severe cardiovascular, respiratory, or other medical comorbidities contraindicated for surgery
  • Currently pregnant
  • BMI ≥35
  • Significant uterine pathology (large fibroids, adenomyosis)
  • Prior chemotherapy or immunotherapy with significant residual toxicity

NCT06424522

Low Anterior Resection Syndrome: Retrograde Enema Program vs Medical Management

Organization/Sponsor: Ohio State University Comprehensive Cancer Center


Example patient: A 62-year-old male with moderate LARS following proctectomy for rectal cancer two years ago, who has tried standard medical management for five months without symptom improvement and has no active cancer or recent treatments.

Phase N/A

Interventions

  • Diagnostic Procedure: X-Ray Imaging
    Summary: X-ray imaging used for diagnostic purposes to detect and monitor tumors and assess treatment response, not a direct therapeutic intervention (Summary of Web Search).
  • Assessment Tool: Questionnaire Administration
    Summary: Patient self-reported outcome measure to assess quality of life, psychological and physical impacts, and subjective treatment experiences (NCI Thesaurus, Summary of Web Search).
  • Procedure: Physical Therapy
    Summary: Treatment using mechanical force and movement including active and passive exercises to ameliorate injury, increase mobility, and improve function (NCI Thesaurus).
  • Drug: Loperamide Hydrochloride
    Summary: Synthetic opioid agonist acting on intestinal mu-receptors to decrease gastrointestinal motility and reduce diarrhea by slowing intestinal transit and increasing water absorption (FDA label, NCI Thesaurus).
  • Procedure: Enema Administration
    Summary: Insertion or injection of substance through the anus to stimulate bowel evacuation or assist with diagnosis of bowel abnormalities (NCI Thesaurus).
  • Dietary Supplement: Dietary Fiber
    Summary: Dietary component that may improve gut health, reduce inflammation, alter gut microbiota, and reduce harmful metabolites (Summary of Web Search).

Key Inclusion

  • Age ≥ 18 years old
  • Moderate to Severe LARS diagnosis
  • History of rectal cancer treated with proctectomy
  • Standard medical management without improvement for 3-6 months

Key Exclusion

  • Significant stricture needing definitive surgical management
  • Chemo or radiation therapy in last 6 months
  • Currently have colorectal cancer or recurrent colorectal cancer
  • Colorectal surgical procedure within last three months
  • Progressive neurological disease
  • Active or recurrent sacral infection
  • Active sacral nerve simulator
  • Pregnant or planning pregnancy during treatment

NCT06802172

Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial Genomic-based

Organization/Sponsor: Fred Hutchinson Cancer Center


Example patient: A 55-year-old Alaska Native woman with newly diagnosed HER2-positive stage II breast cancer, BMI 22, starting neoadjuvant chemotherapy with no prior cancer treatment or neuropathy.

Phase N/A

Interventions

  • Behavioral: Health coaching
    Summary: Health coaching targets cancer survivors to improve physical activity, diet, and quality of life through 1-on-1 support and mentoring, showing benefits in exercise adherence and well-being (NCI Thesaurus, Web Search).
  • Procedure: Biospecimen Collection
    Summary: Collection of tissue and fluid samples to analyze genetic and molecular features for understanding cancer mechanisms and developing targeted therapies (NCI Thesaurus, Web Search).
  • Other: Questionnaire Administration
    Summary: Patient self-reported outcome assessment measuring quality of life, psychological and physical impacts of treatment in cancer patients (NCI Thesaurus, Web Search).
  • Behavioral: Time-restricted eating
    Summary: Dietary intervention limiting food intake to an 8-hour window, potentially reducing chemotherapy toxicity and improving outcomes through metabolic and hormonal changes (Web Search).

Key Inclusion

  • Self-identify as Alaska Native or American Indian eligible for ANMC care
  • Age 21 years or older
  • Stage II-IV rectal cancer (neoadjuvant) or HER2+/triple negative breast cancer stage I-III (neoadjuvant)
  • BMI at least 18.5 kg/m2
  • Planned neoadjuvant or adjuvant therapy duration over 3 months
  • Completed 4 weeks or less of treatment prior to enrollment
  • Food security score under 4 or dietitian clearance if score over 5

Key Exclusion

  • History of cytotoxic chemotherapy within 12 months prior to diagnosis (neoadjuvant)
  • Any prior pelvic radiotherapy
  • Active second malignancy requiring systemic therapy
  • Pre-existing grade 3 or higher neuropathy
  • Receiving parenteral or enteral nutrition
  • Pregnant or breastfeeding
  • Overnight shift work more than 1 day per week
  • Already adhering to less than 10-hour eating window

NCT07219238

A Phase 2/3, Multicenter, Open-Label, Non-Randomized Study to Evaluate Diagnostic Performance of GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT) for Detection of Peritoneal Carcinomatosis (PC) in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)

Organization/Sponsor: GE Healthcare


Example patient: A 62-year-old woman with biopsy-confirmed ovarian cancer and suspected peritoneal carcinomatosis on CT imaging, ECOG status 1, scheduled for cytoreductive surgery after completing neoadjuvant chemotherapy, with normal renal and hepatic function.

Phase 2, Phase 3

Interventions

  • Diagnostic Imaging Agent: GEH300079 (68Ga) Injection PET/CT
    Summary: GEH300079 is a gallium-68 radiolabeled PET imaging agent designed to detect peritoneal carcinomatosis by targeting cancer cells for visualization during PET/CT scanning (Source: Web Search Summary).

Key Inclusion

  • Age ≥18 years
  • Histopathologically confirmed primary colorectal, gastric, ovarian cancer, or PDAC
  • Known or suspected peritoneal carcinomatosis
  • Scheduled for peritoneal surgery with curative intent, surgical exploration, or laparoscopy
  • Treatment-naïve or completed systemic treatment before imaging
  • ECOG performance status ≤2

Key Exclusion

  • Pregnant or breast-feeding
  • Non-resectable extra-abdominal metastasis and/or >3 hepatic metastases
  • Active infection requiring systemic therapy
  • Renal impairment (eGFR <60 mL/min Phase 2; <30 mL/min Phase 3)
  • Severe hepatic impairment (AST/ALT >2.5× ULN or >5× ULN with liver metastases)
  • Autoimmune disease requiring systemic treatment in past 2 years
  • Received investigational agent within 28 days
  • Hypersensitivity to GEH300079 excipients

NCT07407647

Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation

Organization/Sponsor: Ohio State University Comprehensive Cancer Center


Example patient: A 58-year-old postmenopausal woman with rectal cancer who completed curative external beam radiation with concurrent chemotherapy and now experiences vaginal atrophy symptoms.

Phase N/A

Interventions

  • Survey: Survey Administration
    Summary: Self-reported data collection tool to assess patient experiences, symptoms, and quality of life outcomes following radiation treatment (NCI Thesaurus, Web Search).
  • Drug: Prasterone
    Summary: Vaginal insert containing 6.5 mg prasterone, a steroid hormone that treats moderate to severe dyspareunia from vulvar and vaginal atrophy due to menopause by locally restoring vaginal tissue (FDA label, NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Gathering of tissue and fluid samples for research to analyze treatment effects and molecular changes following radiation therapy (NCI Thesaurus, Web Search).

Key Inclusion

  • Anal, rectal, cervical, vaginal, or vulvar cancer receiving curative intent radiation
  • External beam radiation alone or with brachytherapy
  • Concurrent or prior chemotherapy allowed
  • Menopausal: age >50 with no menses for 12 months or bilateral oophorectomy
  • Prior gynecologic or rectal surgery permitted

Key Exclusion

  • Scleroderma, mixed connective tissue disorder, or lupus
  • Prior pelvic radiation
  • Endometrial cancer or hyperplasia
  • History of breast cancer
  • Recent hormone therapy use (estrogen, progestin, DHEA within specified timeframes)
  • Undiagnosed abnormal genital bleeding
  • Palliative radiation therapy
  • Not meeting menopause criteria

NCT07432633

A Phase 1/2 Study of [18F]FPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

Organization/Sponsor: Blue Earth Diagnostics


Example patient: A 62-year-old woman with newly diagnosed stage IIB pancreatic adenocarcinoma, ECOG 1, scheduled for surgical resection in 3 weeks, with no prior cancers or autoimmune conditions.

Phase 1, Phase 2

Interventions

  • PET imaging agent: [18F]FPyQCP
    Summary: [18F]FPyQCP is a PET imaging agent targeting fibroblast activation protein in tumor-associated activated fibroblasts for oncology imaging. Used to visualize FAP expression in colorectal, gastric, pancreatic, lobular breast, and ovarian cancers. Source: Web Search Summary.

Key Inclusion

  • Age 18-79 years
  • ECOG performance status ≤2
  • Diagnosis of CRC, gastric cancer, pancreatic cancer, invasive lobular carcinoma, or ovarian cancer
  • Cohort A: Stage I-III disease or oligometastatic stage IV (≤5 metastases)
  • Cohort B: At least stage IIB disease, treatment-naïve or post-neoadjuvant therapy
  • Cohort B: Scheduled biopsy or surgical resection within 42 days
  • Conventional imaging within 8 weeks of tracer administration

Key Exclusion

  • Prior radioisotope within 5 half-lives
  • Recent contrast agent use (<24 hours IV, <5 days oral)
  • Autoimmune or inflammatory disorder confounding imaging
  • Abdomino-pelvic or breast irradiation within 3 months
  • Significant renal or hepatic impairment
  • Cohort A: Prior history of any other cancer
  • Pregnancy or breastfeeding without milk discarding commitment

NCT07487168

Phase 1 Single Center Study to Evaluate Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Single Agent Mitomycin C (MMC) in Peritoneal Carcinomatosis (PC) From Solid Gastrointestinal Malignancies (sGI-PC) in Palliative Setting

Organization/Sponsor: H. Lee Moffitt Cancer Center and Research Institute


Example patient: A 62-year-old man with ECOG 1 performance status and peritoneal carcinomatosis from colorectal adenocarcinoma with PCI score of 18, who completed 5 months of FOLFOX chemotherapy but is ineligible for cytoreductive surgery due to extensive peritoneal disease.

Phase 1

Interventions

  • Procedure: Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC)
    Summary: Administration of pharmaceutical agents directly into the peritoneal cavity as an aerosolized delivery method, widely utilized for chemotherapeutic treatment of advanced cancers (NCI Thesaurus).
  • Drug: Mitomycin C (MMC)
    Summary: Antibiotic-derived alkylating agent that generates oxygen radicals, alkylates DNA, and produces interstrand DNA cross-links to inhibit DNA synthesis, preferentially toxic to hypoxic cells, used for disseminated adenocarcinoma (FDA label, NCI Thesaurus).

Key Inclusion

  • Histologically confirmed peritoneal disease from colorectal, small bowel, or high grade appendiceal adenocarcinoma
  • Ineligible for CRS/HIPEC due to PCI ≥16, inability to achieve complete cytoreduction, or patient decline
  • Age 18 years or older
  • Completed at least 4 months of first-line systemic therapy (5-FU based with or without biologic therapy)
  • ECOG Performance status 0 or 1
  • Adequate organ and marrow function (ANC ≥1500/mcL, platelets ≥100,000/mcL, creatinine ≤1.5x ULN)
  • Women of child-bearing potential must use adequate contraception
  • Life expectancy greater than 6 months

Key Exclusion

  • Received targeted therapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks for VEGF inhibitors)
  • Residual toxicities >Grade 1 from prior anti-cancer therapy except alopecia and neuropathy <2
  • Extensive metastatic liver disease (>50% liver volume) or brain metastases
  • Bowel obstruction or need for nutritional support (TPN or tube feeds)
  • History of allergic reactions to MMC, fluoropyrimidines, or anesthesia medications
  • Pregnant or breastfeeding women
  • Inability to safely perform laparoscopy due to adhesions or extensive prior surgery
  • History of thromboembolic complications that cannot discontinue anticoagulation perioperatively

NCT07162337

BILMOD: BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention

Organization/Sponsor: Massachusetts General Hospital


Example patient: A 52-year-old weight-stable adult with BMI 28 who had an adenoma removed during recent colonoscopy, consumes a typical Western diet, and takes no regular aspirin or anticoagulants.

Phase N/A

Interventions

  • Behavioral: Increased Plant-Based Diet and Decreased Animal-Based Diet
    Summary: Dietary intervention increasing plant-based foods and decreasing animal-based foods to modify bile acid-gut microbiome axis, reduce inflammation, and improve gut health for colorectal cancer prevention (Source: Web Search).

Key Inclusion

  • Underwent screening or surveillance colonoscopy with removal of at least one adenoma
  • Age 18-80 years
  • Habitually consume a Western pattern diet
  • BMI 18.5 to <35 kg/m2
  • Weight stable in last 3 months (loss or gain <4%)

Key Exclusion

  • Strict dietary patterns (vegan, carnivore, kosher, low-carb)
  • Inflammatory bowel disease, liver or kidney disease, bleeding diathesis
  • Prior gastrointestinal cancer or active cancer treatment within 3 years
  • Familial Adenomatous Polyposis or Lynch Syndrome
  • Current anticoagulant use with unwillingness to discontinue
  • Regular aspirin use
  • Antibiotic or probiotic use
  • Pregnant or breastfeeding

NCT07488676

A Phase 1b/2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants With CLDN18.2-expressing Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma, Pancreatic Adenocarcinoma or Other Solid Tumor Types Genomic-based

Organization/Sponsor: Astellas Pharma Inc


Example patient: A 58-year-old woman with CLDN18.2-positive metastatic gastric adenocarcinoma, ECOG 1, who progressed after one line of chemotherapy and has no brain metastases or significant cardiac disease.

Phase 1, Phase 2

Interventions

  • Drug: ASP546C
    Summary: ASP546C is an antibody-drug conjugate targeting CLDN18.2-positive solid tumors. It delivers cytotoxic agents directly to cancer cells expressing CLDN18.2, currently in Phase 3 trials for various malignancies including breast cancer. Source: Web Search Summary.

Key Inclusion

  • Histologically confirmed gastroesophageal, pancreatic, or pan-tumor adenocarcinoma
  • Tumor expresses CLDN18.2
  • Radiologically confirmed unresectable locally advanced or metastatic disease
  • Received at least 1 prior line of therapy for advanced disease
  • ECOG performance status 0 or 1
  • Life expectancy ≥12 weeks
  • Measurable disease per RECIST v1.1 (Cohorts 1-3)
  • Adequate laboratory parameters within 14 days

Key Exclusion

  • More than 2 prior lines of therapy for advanced disease (Cohorts 1-3)
  • Symptomatic or untreated brain metastases
  • Active autoimmune disease requiring high-dose steroids
  • Significant cardiovascular disease within 6 months
  • Prior CLDN18.2 antibody-drug conjugate treatment
  • Active infection requiring systemic therapy within 7 days
  • Known peripheral neuropathy >grade 1
  • HER2 positive status (gastroesophageal cohorts only)

NCT07337590

Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar

Organization/Sponsor: Exero Medical Ltd.


Example patient: A 58-year-old man with rectal cancer scheduled for elective low anterior resection with anastomosis 8 cm from the anal verge, requiring surgical drain placement and no implanted electronic devices.

Phase N/A

Interventions

  • Device: xBar™ System
    Summary: The xBar™ System is a surveillance device that evaluates clinical outcomes after colorectal surgery by monitoring anastomotic recovery processes through real-time enhanced sensing (source: Web Search).

Key Inclusion

  • Adults ≥21 years scheduled for elective low anterior resection due to colorectal cancer
  • Expected anastomosis within 10 cm from the anal verge
  • Usage of drain during surgery
  • Willing and able to comply with study follow-up and provide informed consent

Key Exclusion

  • Subjects with benign disease
  • Contraindication for surgery and/or general anesthesia
  • Known pregnancy or lactation
  • Prophylactic stoma formation during index surgery
  • Electronic devices implanted in chest or abdominal cavity
  • Allergic reactions to silicone, rubber, or stainless-steel
  • Participation in another interventional study during xBar system usage

NCT06641310

Phase 1a/b Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP) Genomic-based

Organization/Sponsor: University of Michigan Rogel Cancer Center


Example patient: A 32-year-old inactive adult with APC germline mutation and intact rectum post-colectomy, presenting with 8 rectal polyps >2mm, no cancer history for 2 years, and home space for treadmill installation.

Phase 1

Interventions

  • Behavioral: Exercise Therapy
    Summary: A treatment from Complementary and Alternative Medicine using movement methods to enhance physical, mental, and emotional health (NCI Thesaurus).

Key Inclusion

  • FAP with APC germline mutation or >50 colorectal adenomas
  • Intact rectum post-colectomy with ileocolonic anastomosis or pre-colectomy
  • ≥5 rectal polyps >2 mm on baseline endoscopy
  • No invasive cancer for 6 months prior to screening
  • Inactive: ≤60 minutes moderate/strenuous exercise per week
  • Adults ≥18 years of age
  • Access to treadmill at home or approved location
  • No contraindications to regular exercise per PAR-Q+

Key Exclusion

  • History of total proctocolectomy
  • High-grade dysplasia or cancer on screening biopsy
  • History of pelvic radiation
  • Pregnant women
  • Uncontrolled cardiac, psychiatric, or metabolic illness
  • Receiving other investigational agents

NCT07209215

ULtra sensiTive ctDNA-Informed Management eArly-stage recTal cancEr (ULTIMATE) Genomic-based

Organization/Sponsor: University of California, Davis


Example patient: A 62-year-old patient with newly diagnosed non-metastatic rectal adenocarcinoma, no prior cancer treatment, not on hemodialysis, willing to undergo ctDNA testing and total neoadjuvant therapy.

Phase N/A

Interventions

  • Diagnostic Test: Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT)
    Summary: Signatera is a highly sensitive blood test detecting circulating tumor DNA (ctDNA) by identifying unique tumor-specific mutations to guide treatment, predict relapse, and monitor recurrence in colorectal cancer. Source: Summary of Web Search.

Key Inclusion

  • Tumor tissue histologically confirming rectal adenocarcinoma available for Natera ctDNA assay
  • Cohort A: Patients appropriate for receiving TNT including chemotherapy and chemoradiation
  • Cohort B: TNT with at least 4 cycles CAPEOX or 6 cycles FOLFOX and at least 45 Gy in 25 fractions
  • Patients ≥18 years of age at time of consent
  • Ability to understand and willingness to sign informed consent
  • Willingness to adhere to study visit schedule and protocol procedures

Key Exclusion

  • Prior treatment for rectal cancer, except for cohort B
  • Evidence of distant metastatic disease on staging imaging within 8 weeks of enrollment
  • Patients on hemodialysis
  • Any condition interfering with participant safety or compliance

NCT07540572

An Open Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDE574 as Monotherapy in Locally Advanced or Metastatic Solid Tumors and as Combination Therapy With Fulvestrant in Locally Advanced or Metastatic ER+, HER2- Breast Cancer Genomic-based

Organization/Sponsor: IDEAYA Biosciences


Example patient: A 58-year-old postmenopausal woman with metastatic ER+, HER2- breast cancer who progressed after treatment with letrozole and palbociclib, ECOG PS 1, with adequate organ function and no brain metastases.

Phase 1

Interventions

  • Drug: IDE574
    Summary: IDE574 is a dual inhibitor of KAT6/7 enzymes designed to block cancer growth in breast cancer and other solid tumors, currently in Phase 1 trials (Web Search).
  • Drug: Fulvestrant injection
    Summary: Fulvestrant is an estrogen receptor antagonist that degrades estrogen receptors to block estrogen signaling in hormone receptor-positive, HER2-negative advanced breast cancer, administered via intramuscular injection (FDA label).

Key Inclusion

  • Advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, or MSS colorectal adenocarcinoma
  • Progressed on/after at least one line of standard therapy or intolerant to additional effective therapies
  • ER+, HER2- breast cancer progressed after at least 1 prior endocrine therapy and CDK4/6 inhibitor
  • ECOG performance status ≤1
  • Adequate bone marrow, renal and liver function
  • Life expectancy >3 months
  • Archival tissue sample for testing
  • Able to retain orally administered study treatment

Key Exclusion

  • Known symptomatic brain metastases or leptomeningeal metastasis
  • Known primary CNS malignancy or other malignancies within 2 years
  • Impairment of GI function that may alter absorption of IDE574
  • Active liver or biliary disease
  • Active, uncontrolled bacterial, fungal, or viral infection
  • Clinically significant cardiac abnormalities or blood clotting events within 6 months
  • Prior irradiation to >25% of bone marrow
  • Known or suspected hypersensitivity to IDE574 or fulvestrant

NCT07284849

A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer Genomic-based

Organization/Sponsor: Incyte Corporation


Example patient: A 58-year-old with ECOG 1, newly diagnosed stage IV microsatellite stable colorectal adenocarcinoma with liver metastases, no BRAF V600E mutation, no prior systemic therapy for metastatic disease, and adequate organ function.

Phase 3

Interventions

  • Biologic: INCA33890
    Summary: A bispecific antibody targeting PD-1 and TGF-beta receptor II to block immune checkpoint inhibition and TGF-beta-mediated immunosuppression, enhancing T-cell and NK cell activity against tumors (NCI Thesaurus).
  • Other: Placebo
    Summary: An inactive compound identical in appearance to the active treatment, used to distinguish drug action from placebo effects in controlled trials (NCI Thesaurus).
  • Biologic: Bevacizumab
    Summary: A recombinant humanized monoclonal antibody that inhibits VEGF to block tumor angiogenesis, FDA-approved for metastatic colorectal cancer and other advanced cancers (FDA label, NCI Thesaurus).
  • Drug: FOLFOX
    Summary: A chemotherapy regimen combining 5-FU, leucovorin, and oxaliplatin to kill cancer cells, used in colorectal cancer treatment including metastatic disease (Summary of Web Search).

Key Inclusion

  • Stage IV colorectal adenocarcinoma not amenable to curative resection
  • No prior systemic treatment for unresectable or metastatic disease
  • Adjuvant or neoadjuvant therapy allowed if no recurrence within 12 months of end of treatment
  • Measurable disease per RECIST v1.1
  • ECOG performance status of 0 or 1
  • Adequate organ function determined by laboratory results

Key Exclusion

  • MSI-H/dMMR per historical data in the medical record
  • BRAF V600E mutation per historical data in the medical record
  • Untreated and/or progressing CNS metastases
  • History of other malignancy within 2 years
  • Treatment with anti-PD-(L)1 or immune checkpoint inhibitor within last 3 years
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • Significant concurrent and/or uncontrolled medical condition
  • History of organ transplant including allogeneic stem cell transplantation