Sophic Logo gordian knotOvarian and Endometrial Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in May 2026


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


Overview

Number of Trials: 8

These eight trials span diverse cancer types including ovarian, endometrial, gastroesophageal, pancreatic, colorectal, lung, and breast cancers. Studies include novel therapeutics (PARP inhibitors, antibody-drug conjugates, immune checkpoint inhibitors), diagnostic imaging agents, genetic testing education, lifestyle interventions for PCOS-related cancer risk, and psychosocial interventions for fear of progression. Most trials target advanced or metastatic disease with prior treatment failure, while some focus on early-stage disease monitoring or prevention. Common themes include biomarker-driven enrollment, multi-line therapy resistance, and quality-of-life endpoints.

Common Criteria Across Trials

Common Inclusion

  • Age 18 years or older
  • Histologically or cytologically confirmed cancer diagnosis
  • Measurable or evaluable disease per RECIST v1.1
  • ECOG performance status 0-2
  • Adequate organ function (bone marrow, hepatic, renal, cardiac)
  • Prior standard therapy or progression on standard treatment
  • Negative pregnancy test for women of childbearing potential
  • Use of effective contraception during study and follow-up
  • Signed informed consent

Common Exclusion

  • Pregnant or breastfeeding women
  • Active uncontrolled infection requiring systemic therapy
  • Symptomatic or untreated brain metastases
  • History of other malignancies within 3-5 years (except adequately treated skin cancer or carcinoma in situ)
  • Active autoimmune disease requiring systemic immunosuppression
  • Significant cardiovascular disease (myocardial infarction, unstable angina, congestive heart failure within 3-6 months)
  • QTc prolongation (>450-480 msec)
  • Active hepatitis B, hepatitis C, or HIV infection (unless controlled)
  • Prior severe adverse reactions to similar therapies
  • Concurrent enrollment in other interventional trials

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


NCT07419841

A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-10726 in Patients With Advanced Malignancies Genomic-based

Organization/Sponsor: Compass Therapeutics


Example patient: A 62-year-old woman with MSI-high metastatic endometrial cancer who progressed after three cycles of pembrolizumab and prior platinum-based chemotherapy, with ECOG status 1 and adequate organ function.

Phase 1

Interventions

  • Drug: CTX-10726
    Summary: CTX-10726 is an investigational cancer treatment targeting advanced or surgically unremovable malignancies including endometrial cancer. Specific mechanism of action not disclosed. Source: Web Search Summary.

Key Inclusion

  • Age 18 years or older
  • Endometrial cancer patients received at least 1 cycle of platinum-based chemotherapy
  • MSI-high or dMMR endometrial tumors progressed after minimum 2 doses PD-1/PDL1 treatment
  • Measurable disease per RECIST 1.1
  • ECOG performance status 0-1
  • Adequate bone marrow, hepatic, renal, and cardiac function
  • Prior anticancer therapy >28 days or 2 half-lives before first dose
  • Resolution of prior therapy toxicities to Grade 2 or less

Key Exclusion

  • Clinically significant adverse reaction to prior PD-1/PD-L1 therapy leading to discontinuation
  • Prior organ transplantation
  • Symptomatic or uncontrolled CNS/brain metastasis
  • Active autoimmune disease requiring chronic steroids >10 mg/day prednisone equivalent
  • Active hepatitis B, C, or HIV infection not adequately controlled
  • Pregnant or lactating women
  • Poorly controlled hypertension (>140/90 mmHg despite ≥3 medications)
  • Active or prior idiopathic pulmonary fibrosis or interstitial lung disease

NCT07090109

Partnering to Impact Testing in the Commonwealth for Hereditary Cancers (PITCH)

Organization/Sponsor: University of Kentucky


Example patient: A 52-year-old woman recently diagnosed with stage II endometrial cancer who has not previously undergone multi-gene panel testing for hereditary cancers.

Phase N/A

Interventions

  • Educational: Genetic testing education video
    Summary: Educational videos designed to increase knowledge and rates of genetic testing in ovarian and endometrial cancer patients by providing visual and verbal information to improve understanding of DNA analysis for genetic alterations indicating increased cancer risk (NCI Thesaurus, Web Search).

Key Inclusion

  • Diagnosed with a cancer that can be associated with hereditary forms of cancer

Key Exclusion

  • Previously undergone multi-gene panel testing for hereditary cancers

NCT06930755

Study of NMS-03305293, a Non-Trapping PARP1-Specific PARP Inhibitor in Relapsed Ovarian Cancer Genomic-based

Organization/Sponsor: Nerviano Medical Sciences


Example patient: A 58-year-old woman with high-grade serous ovarian cancer, BRCA wild-type, ECOG status 1, who has progressed after 4 prior lines of chemotherapy without prior PARP inhibitor or topoisomerase inhibitor exposure, with measurable peritoneal disease by CT scan.

Phase N/A

Interventions

  • Drug: NMS-03305293
    Summary: An orally bioavailable PARP1 inhibitor that selectively binds to PARP and prevents DNA repair of single-strand breaks, enhancing DNA damage accumulation and promoting apoptosis in cancer cells, studied for BRCA wild-type ovarian cancer (NCI Thesaurus, Web Search).
  • Drug: Topotecan
    Summary: A topoisomerase I inhibitor that stabilizes topoisomerase I-DNA complexes during S phase, preventing DNA religation and producing lethal double-strand breaks, FDA-approved for recurrent ovarian and cervical cancer (FDA label, NCI Thesaurus).

Key Inclusion

  • High-grade serous epithelial ovarian, fallopian tube or peritoneal cancer
  • No more than 5 prior lines of therapy
  • Failed all evidence based local standards of care
  • ECOG performance status ≤2
  • Radiographic progression on most recent anticancer therapy
  • Measurable disease by RECIST v1.1
  • Resolution of acute toxic effects to Grade ≤1
  • Childbearing potential must use highly effective contraception

Key Exclusion

  • BRCA mutation
  • Prior therapy with PARP inhibitor outside approved indication
  • Prior therapy with topoisomerase inhibitors including ADC payloads
  • Low-grade or borderline ovarian tumor
  • Prior wide-field radiotherapy affecting ≥20% bone marrow
  • QTc interval ≥450 milliseconds
  • Active second malignancy
  • Symptomatic or untreated CNS lesions

NCT07571915

Health-Related Quality of Life and Metabolic Outcomes in PCOS: A Feasibility Study of Comprehensive PCOS Education and Lifestyle Modification Support Delivered Via Synchronous Virtual Groups

Organization/Sponsor: The Cleveland Clinic


Phase N/A

Interventions

  • Behavioral: Intervention Group
    Summary: Comprehensive PCOS education and lifestyle modification support delivered via synchronous virtual groups targeting metabolic and quality of life outcomes in PCOS patients with obesity.

Key Inclusion

  • Non-pregnant females ages 18-49 years
  • Preexisting diagnosis of PCOS
  • Obesity with BMI ≥30 kg/m2 at enrollment

Key Exclusion

  • Pregnant or planning pregnancy during study
  • Recent PCOS-focused group participation (<12 months)
  • Documented monogenic obesity
  • Diagnosis of any type of diabetes (excluding prediabetes)
  • Systemic glucocorticoid therapy >7 days at enrollment
  • End-stage organ disease
  • No internet access
  • Requiring English language interpretation

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 ovarian mucinous carcinoma who has progressed after one line of platinum-based chemotherapy, has an ECOG performance status of 1, no brain metastases, and adequate organ function.

Phase 1, Phase 2

Interventions

  • Drug: ASP546C
    Summary: ASP546C is an antibody-drug conjugate targeting CLDN18.2 that delivers cytotoxic agents to CLDN18.2-positive cancer cells in solid tumors including breast, gastroesophageal, and pancreatic cancers. Source: Web Search.

Key Inclusion

  • Histologically confirmed gastroesophageal adenocarcinoma, pancreatic adenocarcinoma, or pan-tumor including ovarian mucinous carcinoma or invasive breast cancer
  • Tumor expresses CLDN18.2
  • Radiologically confirmed unresectable locally advanced or metastatic disease within 28 days prior to first dose
  • Received at least 1 line of therapy for unresectable locally advanced or metastatic disease
  • ECOG performance status of 0 or 1
  • Predicted life expectancy ≥12 weeks
  • Measurable disease per RECIST v1.1 (Cohorts 1-3) or evaluable disease (Cohort 4)
  • Adequate contraception for women of childbearing potential and male participants

Key Exclusion

  • More than 2 prior lines of therapy for unresectable locally advanced or metastatic disease (Cohorts 1-3)
  • Symptomatic or untreated brain metastases or meningeal carcinomatosis
  • Unresolved pneumonitis or history of non-infectious pneumonitis requiring glucocorticoids within 6 months
  • Active infection requiring systemic therapy not resolved within 7 days prior to first dose
  • Significant cardiovascular disease including congestive heart failure Class III/IV or myocardial infarction within 6 months
  • QTc interval >470 msec
  • Prior CLDN18.2 ADC treatment
  • Known peripheral neuropathy >grade 1

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 55-year-old woman with histologically confirmed stage III ovarian cancer and suspected peritoneal carcinomatosis on imaging, ECOG performance status 1, scheduled for cytoreductive surgery, with normal renal and hepatic function.

Phase 2, Phase 3

Interventions

  • Diagnostic Test: GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT)
    Summary: GEH300079 (68Ga) is a radioactive gallium-68 imaging agent used with PET/CT to detect peritoneal carcinomatosis by targeting and visualizing cancer cells in patients with colorectal, gastric, ovarian, or pancreatic cancers (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
  • Severe claustrophobia or unable to tolerate PET/CT scan
  • Known hypersensitivity to GEH300079 (68Ga) excipients

NCT07339384

Circulating Tumor DNA Assessment in Early-Stage Endometrial Cancer (SIGNAL-EMC 101) Genomic-based

Organization/Sponsor: Natera, Inc.


Example patient: A 65-year-old woman with FIGO Stage I grade 2 endometrioid endometrial cancer with outer half myometrial invasion and lymphovascular invasion, status post hysterectomy and bilateral pelvic lymphadenectomy with negative lymph nodes and negative peritoneal cytology.

Phase N/A

Interventions

  • Diagnostic Test: Signatera Genome ultra-sensitive ctDNA blood test
    Summary: Ultra-sensitive circulating tumor DNA blood test that detects molecular residual disease and assesses treatment response in solid tumors with high sensitivity and specificity, used for cancer monitoring and recurrence prediction (NCI Thesaurus, Web Search).

Key Inclusion

  • Age 18 years or older
  • FIGO 2009 Stage I endometrial cancer after hysterectomy and lymph node assessment
  • Endometrioid histology with age-stratified uterine risk factors for HIR cohort
  • High risk histology including serous, clear cell, carcinosarcoma, or mixed for observation cohort
  • FIGO 2009 Stage II endometrioid for high risk observation cohort
  • Low risk Stage I endometrioid with absent or insufficient uterine risk factors for low risk cohort
  • Bilateral pelvic lymphadenectomy or sentinel lymph node dissection performed
  • Negative peritoneal cytology if performed

Key Exclusion

  • Undifferentiated or dedifferentiated histology
  • Uterine sarcoma
  • Prior pelvic radiation therapy
  • Positive pelvic washings
  • Pelvic lymph node assessment not performed
  • Isolated tumor cells in lymph nodes
  • Prior therapy for endometrial cancer including hormonal, chemotherapy, targeted, or immunotherapy
  • Active malignancy within last five years except non-melanoma skin cancer

NCT07636200

The EASE Study: Randomized Trial of a Novel Approach to Addressing Fear of Progression in Advanced Cancer

Organization/Sponsor: University of Colorado, Boulder


Example patient: A 52-year-old woman with recurrent Stage III ovarian cancer, ECOG status 1, experiencing significant fear of disease progression and cancer-related distress, with no psychiatric history or cognitive impairment.

Phase N/A

Interventions

  • Behavioral: Written Exposure-Based Coping Intervention (EASE)
    Summary: A structured writing-based psychological intervention targeting fear of cancer progression and trauma symptoms through exposure therapy techniques to reduce distress in advanced cancer patients (Summary of Web Search).
  • Other: Usual Care Control Condition
    Summary: Standard treatment protocols without experimental psychological interventions, serving as a benchmark comparator (Summary of Web Search).

Key Inclusion

  • Adults age 18 or older
  • Stage III ovarian cancer that has recurred
  • Stage IV metastatic cancer of any solid tumor type
  • ECOG Performance Status ≤2
  • Elevated fear of progression (FoP-Q mean ≥2.5 or total ≥30)
  • Elevated trauma symptoms (IES-R mean ≥1.5 or total ≥33)
  • Fluent in English or Spanish

Key Exclusion

  • History of chronic untreated trauma unrelated to cancer
  • Psychiatric hospitalization in past 2 years
  • Suicide attempt in past 2 years
  • Current high suicide risk
  • Cognitive impairment such as dementia