Sophic Logo gordian knotOvarian and Endometrial Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in March 2026


Powered by Sophic Starlight


Disclaimer and Important Notice:

Sophic does not practice medicine nor provide medical advice. The Sophic Starlight Cancer Clinical Trials Intelligence Report is provided for educational and consulting purposes only. This report is not a substitute for professional medical advice, diagnosis, or treatment. Sophic shall not be held responsible for any interpretation, application, or use of this report beyond these purposes.

The Sophic Starlight Cancer Clinical Trials Intelligence Report is intended solely as an educational resource that provides access to publicly available clinical trial data integrated within Sophic’s proprietary knowledgebase and summarized with AI. Reports are provided entirely free of charge, and patients should never be billed or charged for access to this information. Users agree to reference Sophic in any publication, presentation, or publicity that incorporates or relies upon information from Sophic Starlight Cancer Clinical Trials Intelligence Reports.


1: Summary data from new trials identified for Ovarian and Endometrial Cancer.


Overview

Number of Trials: 9

These nine trials investigate diverse interventions for gynecologic, gastrointestinal, and other solid tumors. Studies include novel antibody-drug conjugates (ADCs) targeting MUC16, CLDN18.2, and B7-H3; imaging agents for peritoneal carcinomatosis and fibroblast activation protein; progestin therapy for endometrial cancer; probiotic interventions during chemotherapy; fertility preservation via utero-ovarian transposition; alternative goserelin injection sites for ovarian suppression; and diagnostic PET imaging. Most trials focus on advanced or metastatic disease, with emphasis on ovarian, endometrial, gastric, pancreatic, colorectal, and breast cancers.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years
  • Histologically or cytologically confirmed cancer diagnosis
  • ECOG performance status 0-2
  • Adequate organ function (liver, kidney, hematologic parameters)
  • Life expectancy ≥3-12 weeks
  • Measurable or evaluable disease per RECIST v1.1
  • Signed informed consent
  • Willingness to comply with study procedures

Common Exclusion

  • Active uncontrolled infection
  • Pregnancy or breastfeeding
  • Symptomatic or untreated brain metastases
  • Severe cardiovascular disease (NYHA Class III-IV, recent MI)
  • QTc prolongation >470 ms
  • History of interstitial lung disease or pneumonitis
  • Active autoimmune disease requiring systemic steroids
  • Prior hypersensitivity to study agents
  • Unresolved toxicities from prior therapy
  • HIV, active hepatitis B or C infection

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


NCT07436793

Evaluating Promising Progestins in Endometrial Cancer Through a Rotating Umbrella Surgical Window Trial - The PRO-WINDOW TRIAL for Endometrial Cancer

Organization/Sponsor: New Mexico Cancer Research Alliance


Example patient: A 52-year-old woman with newly diagnosed grade 2 endometrioid endometrial adenocarcinoma, ECOG performance status 1, scheduled for hysterectomy, with no history of thromboembolic disease or prior hormonal therapy.

Phase N/A

Interventions

  • Drug: Progesterone Only Hormone Replacement Therapy
    Summary: Progesterone injection is a progestin that provides exogenous progesterone to restore hormonal balance and regulate uterine bleeding, indicated for amenorrhea and abnormal uterine bleeding when organic pathology is excluded (FDA label).
  • Drug: Megestrol Acetate
    Summary: Megestrol acetate is a synthetic progestin with antineoplastic properties indicated for palliative treatment of advanced endometrial and breast carcinomas, working by binding progesterone receptors and blocking estrogen-sensitive tumor growth (FDA label, NCI Thesaurus).
  • Procedure: Hysterectomy
    Summary: Surgical procedure to remove the uterine body (partial) or uterine body and cervix (total) (NCI Thesaurus).
  • Procedure: Curettage Procedure
    Summary: Removal of tissue using a curette device, a spoon-shaped instrument with a sharp edge (NCI Thesaurus).
  • Procedure: Biopsy Procedure
    Summary: Removal of tissue specimens or fluid for microscopic examination to establish diagnosis (NCI Thesaurus).

Key Inclusion

  • Histologically proven endometrioid endometrial adenocarcinoma by biopsy within 8 weeks
  • Age 18 or older
  • Primary endometrioid adenocarcinoma of uterine corpus, all grades and stages
  • Planned for primary surgical treatment including hysterectomy
  • ECOG performance status 0-3
  • Adequate bone marrow function (platelets ≥100,000, ANC ≥1,500)
  • Adequate renal and hepatic function
  • Formalin-fixed paraffin-embedded tumor tissue available

Key Exclusion

  • Non-endometrioid histology (serous, clear cell, carcinosarcoma, or mixed)
  • Prior progestin or anti-estrogen therapy within 3 months before diagnosis
  • ECOG performance status of 4
  • History of deep venous thrombosis or pulmonary embolism within past 2 years
  • Previous systemic, radiation, or other treatment for uterine cancer
  • Suspected or known peanut allergy
  • Gastrointestinal obstruction or malabsorptive disease precluding oral medications
  • Scant or unavailable tumor tissue from biopsy

NCT07144826

A Randomized, Double-Blind, Placebo Controlled, Study to Investigate Efficacy of a Probiotic Intervention on the Gut and Vaginal Microbiome of Ovarian Cancer Patients Undergoing Treatment With Platinum Chemotherapy

Organization/Sponsor: Ohio State University Comprehensive Cancer Center


Example patient: A 52-year-old woman with stage III recurrent ovarian cancer scheduled to receive carboplatin-based chemotherapy, with adequate neutrophil counts and no history of inflammatory bowel disease or probiotic allergies.

Phase N/A

Interventions

  • Dietary Supplement: Probiotic
    Summary: Live microorganisms including Akkermansia muciniphila, Anaerobutyricum hallii, Clostridium beijerinckii, Clostridium butyricum, and Bifidobacterium infantis designed to support gut health and modulate the microbiome in ovarian cancer patients undergoing platinum-based chemotherapy (Summary of Web Search).
  • Other: Placebo Administration
    Summary: Medically inactive substance used as control to evaluate probiotic efficacy by comparing outcomes against no active treatment (NCI Thesaurus, Summary of Web Search).
  • Procedure: Biospecimen Collection
    Summary: Gathering of tissue and fluid samples to analyze microbiome changes and molecular features in ovarian cancer patients receiving chemotherapy (NCI Thesaurus, Summary of Web Search).
  • Other: Questionnaire Administration
    Summary: Patient self-reported outcome assessment to measure quality of life, psychological and physical impacts of treatment in cancer patients (NCI Thesaurus, Summary of Web Search).

Key Inclusion

  • Age > 18 years old
  • Advanced (stage II, III or IV) or recurrent ovarian cancer
  • Receiving platinum-based chemotherapy (cisplatin, carboplatin)
  • Willingness to sign written consent
  • Agreeable to not take other probiotic/prebiotic supplements during study
  • Agreeable to not make significant dietary changes during study
  • Patients with ileostomy or colostomy permitted

Key Exclusion

  • Borderline ovarian tumors
  • Prior allergy or food intolerance to probiotic products
  • Chronic inflammatory bowel disease requiring medications
  • Active gastric or duodenal ulcer, complete bowel obstruction, active fistula
  • Absolute neutrophil count (ANC) < 1500
  • Hypersensitivity to study product components
  • Hypersensitivity to > 4 first-line antimicrobials against study probiotic strains

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 whole pelvic radiotherapy, BMI 28, normal ovarian reserve markers (FSH 7 IU/L, AMH 2.5 ng/mL), no metastases, who desires future fertility and pregnancy.

Phase 1

Interventions

  • Procedure: Uteroovarian transposition
    Summary: Surgical procedure that relocates the uterus and ovaries away from the pelvic radiation field to preserve fertility by maintaining ovarian function and uterine viability during cancer treatment (Source: Web Search).

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, LH and E2 within normal ranges
  • No distant metastasis confirmed by imaging
  • BMI <35
  • Desire to carry pregnancy in the future

Key Exclusion

  • Advanced cancer stage with locally advanced or metastatic disease
  • Prior pelvic radiotherapy
  • Poor ovarian reserve: FSH >10 IU/L or AMH <1 ng/mL
  • Currently pregnant
  • Severe medical comorbidities contraindicating surgery (cardiovascular, uncontrolled diabetes, severe respiratory disease)
  • Significant uterine pathology (large fibroids, adenomyosis)
  • BMI ≥35
  • Absence of one of the gonadal vessels

NCT07470853

A Phase 1 First-in-Human Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.

Organization/Sponsor: Whitehawk Therapeutics, Inc.


Example patient: A 58-year-old woman with advanced ovarian cancer without CNS metastases, no cardiac disease, QTcF <470 ms, and not pregnant or breastfeeding.

Phase 1

Interventions

  • Antibody Drug Conjugate: HWK-016, MUCIN-16-targeted ADC
    Summary: HWK-016 is an antibody drug conjugate targeting mucin-16 (MUC16, also known as cancer antigen 125 or CA125), designed for treating advanced solid tumors (source: NCI Thesaurus).
  • Monoclonal Antibody: Bevacizumab
    Summary: Bevacizumab is a recombinant humanized monoclonal antibody that inhibits VEGF to block tumor angiogenesis, indicated for ovarian and endometrial cancers, often combined with chemotherapy (sources: FDA label, NCI Thesaurus).

Key Inclusion

  • Endometrial carcinoma (monotherapy escalation, backfill, and expansion cohorts)
  • Ovarian cancer (monotherapy escalation, backfill, and expansion cohorts)
  • Ovarian cancer (combination escalation, backfill, and expansion cohorts)

Key Exclusion

  • Known or suspected uncontrolled CNS metastases
  • History of carcinomatous meningitis
  • Active uncontrolled systemic infection
  • Evidence of corneal keratopathy or history of cornea transplant
  • Significant cardiovascular disease
  • QTcF ≥470 milliseconds
  • History of pneumonitis or interstitial lung disease
  • Pregnant, breastfeeding, or planning to breastfeed during study or within 30 days of last dose

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 histologically confirmed ovarian cancer and suspected peritoneal carcinomatosis on imaging, ECOG status 1, scheduled for cytoreductive surgery after completing neoadjuvant chemotherapy, with normal renal and hepatic function.

Phase 2, Phase 3

Interventions

  • Diagnostic: GEH300079 (68Ga) Injection PET/CT
    Summary: Radioactive gallium-68 imaging agent targeting cancer cells to detect peritoneal carcinomatosis in colorectal, gastric, ovarian, and pancreatic cancers using combined PET/CT imaging (Summary of Web Search, NCI Thesaurus).

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
  • Hypersensitivity to GEH300079 (68Ga) excipients
  • Severe claustrophobia or unable to tolerate PET/CT scan

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 stage IIB epithelial ovarian cancer confirmed by histopathology, ECOG status 1, treatment-naïve, scheduled for surgical resection within 6 weeks, with recent CT imaging showing no distant metastases.

Phase 1, Phase 2

Interventions

  • Diagnostic: [18F]FPyQCP
    Summary: A PET imaging agent targeting fibroblast activation protein in tumor-associated activated fibroblasts for oncology imaging, evaluated in Phase 1/2 trials (Source: Web Search).

Key Inclusion

  • Age 18-79 years
  • ECOG performance status ≤2
  • Diagnosis of CRC, GC, PDAC, ILC, or EOC confirmed by histopathology or cytology
  • Stage I-III disease or oligometastatic stage IV (≤5 metastases) for Cohort A
  • Treatment-naïve with at least stage IIB disease or post-neoadjuvant therapy or suspected recurrence for Cohort B
  • Conventional imaging within 8 weeks of tracer administration
  • Negative pregnancy test for women of childbearing potential
  • Scheduled biopsy or surgical resection no later than Day 42 for Cohort B

Key Exclusion

  • Radioisotope administration within 5 half-lives prior to imaging
  • Recent contrast agent use (<24 hours IV, <5 days oral)
  • Severe claustrophobia or panic attacks in confined spaces
  • Autoimmune or inflammatory disorder expected to confound imaging
  • Abdomino-pelvic or breast irradiation in last 3 months
  • Significant renal or hepatic impairment
  • Breastfeeding without commitment to discard milk for ≥24 hours
  • Prior history of any other cancer (Cohort A only)

NCT07460752

MC250301, OptiOFS: A Randomized Phase II Trial of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Breast Cancer

Organization/Sponsor: Mayo Clinic


Example patient: A 42-year-old premenopausal woman with stage II ER-positive breast cancer in remission after surgery and radiation, currently on monthly goserelin and letrozole for 8 months with good performance status.

Phase II

Interventions

  • Procedure: Questionnaire Administration
    Summary: Patient self-reported outcome assessment measuring quality of life, psychological and physical impacts in breast cancer patients, with no direct biological mechanism (NCI Thesaurus, Web Search).
  • Drug: Goserelin Acetate
    Summary: Hormone therapy that suppresses pituitary gonadotropin release to reduce hormone production, used for ovarian function suppression in hormone receptor positive breast cancer (Web Search).
  • Procedure: Biospecimen Collection
    Summary: Collection of blood and tissue samples to analyze genetic and molecular features for understanding cancer mechanisms and developing targeted therapies (NCI Thesaurus, Web Search).

Key Inclusion

  • Age 18-50 years
  • Histologically or cytologically confirmed hormone positive breast cancer stage I-III (ER IHC >1%)
  • Completed curative intent therapy and clinically in remission
  • Currently receiving monthly goserelin with aromatase inhibitor or tamoxifen for at least 6 months
  • ECOG performance status 0, 1, or 2
  • Negative pregnancy test within 14 days prior to registration
  • Estradiol E2 ≤20 pg/mL after 6 cycles for randomization
  • Willingness to provide blood specimens for correlative research

Key Exclusion

  • Chemotherapy within 6 months prior to registration
  • Receiving any estrogen or progestin containing medications including topical estrogens
  • Planning to discontinue medical ovarian function suppression in next 12 months

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 pancreatic adenocarcinoma, ECOG 1, who progressed after one line of chemotherapy and has measurable liver metastases without brain involvement or active infections.

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 adenocarcinoma, pancreatic adenocarcinoma, or pan-tumor (cholangiocarcinoma, colorectal, NSCLC, SCLC, ovarian mucinous, or breast cancer)
  • Tumor expresses CLDN18.2
  • Radiologically confirmed unresectable locally advanced or metastatic disease within 28 days
  • Received at least 1 prior line of therapy for advanced/metastatic disease
  • ECOG performance status 0 or 1
  • Life expectancy ≥12 weeks
  • Measurable disease per RECIST v1.1 (Cohorts 1-3) or evaluable disease (Cohort 4)
  • Adequate laboratory parameters within 14 days prior to first dose

Key Exclusion

  • Non-adenocarcinoma or mixed histology (Cohorts 1-3)
  • >2 prior lines of therapy for advanced disease (Cohorts 1-3)
  • Symptomatic or untreated brain metastases or meningeal carcinomatosis
  • Active autoimmune disease requiring high-dose systemic steroids
  • Significant cardiovascular disease including NYHA Class III/IV heart failure or MI within 6 months
  • Prior CLDN18.2 antibody-drug conjugate therapy
  • Active infection requiring systemic therapy within 7 days
  • Known HER2 positive status (Cohorts 1-2 gastroesophageal only)

NCT07424547

Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6043 in Patients With Advanced/Metastatic Solid Tumors

Organization/Sponsor: Conjupro Biotherapeutics, Inc.


Example patient: A 62-year-old woman with metastatic breast cancer progressing after standard chemotherapy, ECOG status 1, with measurable lung metastases, LVEF 55%, no cardiac or pulmonary comorbidities, and no prior B7-H3 targeted therapy.

Phase I

Interventions

  • Drug: SYS6043
    Summary: SYS6043 is an antibody-drug conjugate targeting B7-H3, a protein expressed in certain advanced tumors, delivering a cytotoxic payload to cancer cells expressing B7-H3 for treatment of advanced or metastatic solid tumors including breast cancer (Source: Web Search).

Key Inclusion

  • Aged ≥18 years old
  • Advanced/unresectable or metastatic solid tumors confirmed by histology or cytology
  • Disease recurrence or progression during or after standard of care
  • At least one measurable lesion per RECIST V1.1
  • Life expectancy ≥3 months
  • ECOG performance status 0-1
  • LVEF ≥50% by ECHO or MUGA

Key Exclusion

  • Prior B7-H3 targeted therapy
  • Previously received topoisomerase inhibitor antibody-drug conjugate
  • Symptomatic congestive heart failure (NYHA Class II-IV) or severe arrhythmia
  • Myocardial infarction or unstable angina within 6 months
  • QTcF >470 ms on ECG
  • History of interstitial lung disease or non-infectious pneumonia
  • Active clinically significant bacterial, fungal, or viral infection
  • Spinal cord compression or clinically active brain metastasis