Sophic Logo gordian knotOvarian and Endometrial Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in February 2026


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


Overview

Number of Trials: 10

These 10 trials span Phase 1 to Phase 3 studies targeting advanced or metastatic solid tumors, with a strong focus on gynecologic cancers (ovarian, endometrial, cervical, uterine sarcomas) and other malignancies. Interventions include novel targeted therapies (BI 3820768, 177Lu-BetaBart, M7437, THEO-260), antibody-drug conjugates (sacituzumab tirumotecan), selective estrogen receptor degraders (elacestrant), metabolic agents (tirzepatide), and behavioral interventions (physical activity promotion, genetic testing education). Several trials explore radioligand therapy, immunotherapy combinations, and maintenance strategies. Common themes include relapsed/refractory disease, biomarker-driven enrollment, and quality of life improvements.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years
  • Histologically or cytologically confirmed advanced or metastatic solid tumor
  • ECOG performance status 0-2
  • Adequate organ function (liver, kidney, bone marrow)
  • Measurable disease per RECIST v1.1 or similar criteria
  • Life expectancy ≥4-6 months
  • Prior standard therapy completed or disease refractory to standard treatment
  • Willingness to provide informed consent and comply with protocol

Common Exclusion

  • Active or uncontrolled infection requiring systemic therapy
  • Active hepatitis B or C infection
  • Known HIV infection (unless well-controlled on therapy)
  • Untreated or symptomatic brain metastases or CNS involvement
  • Major surgery within 4 weeks prior to enrollment
  • Prior malignancy within 3 years (except non-melanoma skin cancer, carcinoma in situ)
  • Pregnant or breastfeeding
  • Significant cardiovascular disease or QTc prolongation
  • Residual toxicity ≥Grade 2 from prior therapy
  • Receipt of investigational therapy or anticancer treatment within specified washout period

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


NCT07306559

A Phase I Study to Determine the Safety and Tolerability of BI 3820768 in Patients With Advanced Relapsed or Refractory Germ Cell Tumours, Endometrial Cancer, or Ovarian Cancer Genomic-based

Organization/Sponsor: Boehringer Ingelheim


Example patient: A 62-year-old woman with relapsed ovarian cancer, ECOG status 1, target-positive by central testing, who has progressed after multiple lines of chemotherapy and has no active infections.

Phase 1

Interventions

  • Drug: BI 3820768
    Summary: BI 3820768 is a targeted therapy under investigation for advanced or metastatic solid tumors including ovarian and endometrial cancers. Specific targets and mechanisms are not publicly disclosed. Source: Summary of Web Search.

Key Inclusion

  • Age ≥18 years
  • Histologically or cytologically confirmed germ cell tumour, endometrial cancer, or ovarian cancer
  • Advanced, relapsed/refractory disease
  • Disease progression despite conventional treatment or exhausted all established treatment options
  • Confirmed target-positivity for EC and OVC based on central laboratory testing
  • ECOG performance status 0 or 1

Key Exclusion

  • Major surgery within 28 days prior to first dose
  • Other malignancies within past 3 years except effectively treated non-melanoma skin cancers, carcinoma in situ, or ductal carcinoma in situ
  • Known leptomeningeal disease or spinal cord compression
  • Infection requiring systemic antimicrobial treatment within 7 days or clinical signs of infection within 48 hours
  • Active HCV infection with viral load above limit of quantification
  • Active hepatitis B virus infection (positive HBsAg)

NCT07227077

An Adaptive Design for Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial

Organization/Sponsor: Medical College of Wisconsin


Example patient: A 68-year-old English-speaking woman with treated endometrial cancer without metastasis or recurrence who owns a smartphone and experiences chronic pain.

Phase N/A

Interventions

  • Behavioral: Physical Activity Promotion Intervention
    Summary: Uses pedometers and tracking to reduce sedentary behavior and increase exercise, targeting behavior change to improve fatigue, functional ability, muscle strength, and quality of life in cancer survivors (NCI Thesaurus, Web Search).

Key Inclusion

  • Age greater than or equal to 65 years
  • History of bladder, breast, cervical, colorectal, endometrial, lung, or prostate cancer diagnosis and treatment
  • Fluent in spoken and written English
  • Access to smartphone

Key Exclusion

  • Metastatic disease
  • Cancer recurrence

NCT07189871

A Phase 1/2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

Organization/Sponsor: Radiopharm Theranostics, Ltd


Example patient: A 62-year-old woman with metastatic endometrial cancer progressing after two lines of chemotherapy, ECOG status 1, with adequate organ function and no cardiovascular disease.

Phase 1, Phase 2

Interventions

  • Radiopharmaceutical: 177Lu-BetaBart
    Summary: 177Lu-BetaBart is a radiolabeled monoclonal antibody that targets B7-H3 protein on cancer cells, delivering lutetium-177 radiation directly to tumors for targeted radiotherapy. Source: Web Search.

Key Inclusion

  • Age ≥18 years
  • Histopathologically confirmed ovarian, cervical, or endometrial cancer
  • Documented disease progression during or after most recent anticancer therapy
  • Refractory to or intolerant of standard of care therapy or no standard therapy available
  • At least 1 measurable target lesion according to RECIST v1.1 (except CRPC)
  • ECOG performance status ≤2
  • Life expectancy ≥4 months
  • Adequate contraception for 6 months after last dose

Key Exclusion

  • Residual toxicity ≥Grade 2 from prior anticancer therapy (except alopecia and neuropathy)
  • eGFR <50 mL/min, platelet count <100×10⁹/L, ANC <1.5×10⁹/L, hemoglobin <9 g/dL
  • ALT or AST >3×ULN (>5×ULN with liver metastases)
  • Clinically significant cardiovascular disease including NYHA Class II or greater heart failure
  • Major surgery within 4 weeks prior to first dose
  • Anticancer therapy ≤28 days or 5 half-lives prior to first dose
  • Active hepatitis B or C infection
  • Untreated moderate to severe hydronephrosis

NCT07065552

A Pre-Operative Window Study of Tirzepatide in Obesity-Driven Endometrial Cancer

Organization/Sponsor: UNC Lineberger Comprehensive Cancer Center


Example patient: A 52-year-old obese woman with BMI 34 kg/m2 and newly diagnosed early-stage endometrioid endometrial cancer scheduled for hysterectomy, with ECOG status 1 and no diabetes.

Phase N/A

Interventions

  • Drug: Tirzepatide
    Summary: Tirzepatide is a dual GIP and GLP-1 receptor agonist that enhances glucose-dependent insulin secretion and promotes weight management. It is FDA-approved for type 2 diabetes and being studied for metabolic and hormonal effects in obesity-driven endometrial cancer. Sources: FDA label, Web Search.

Key Inclusion

  • Current diagnosis of endometrioid histology cancer
  • Scheduled to undergo hysterectomy and staging
  • Age ≥18 years
  • Body mass index ≥30 kg/m2
  • Presumed clinically early-stage disease confined to uterus
  • ECOG ≤2 or Karnofsky Performance Status >50

Key Exclusion

  • Active infection requiring systemic therapy
  • Pregnant or breast feeding
  • Taking medications that may influence metabolism
  • Taking central nervous system stimulant
  • Known sensitivities to GIP and GLP-1 receptor agonists
  • Type 1 diabetes mellitus or latent autoimmune diabetes
  • Receiving treatment with insulin
  • History of severe hypoglycemia

NCT07467772

A Phase 2 Study Evaluating the Efficacy of Elacestrant in Patients With Estrogen Receptor Positive Uterine Sarcomas

Organization/Sponsor: Dana-Farber Cancer Institute


Example patient: A 62-year-old postmenopausal woman with metastatic ER-positive uterine leiomyosarcoma, ECOG status 1, with measurable lung metastases, adequate organ function, and no active infections.

Phase 2

Interventions

  • Drug: Elacestrant
    Summary: Elacestrant is an orally available selective estrogen receptor degrader (SERD) that binds to estrogen receptor-alpha, inducing conformational change and proteosomal degradation. It blocks ER-mediated signaling and inhibits proliferation in ER-expressing cancers, showing effectiveness against endocrine-resistant tumors. FDA-approved for ER-positive, HER2-negative, ESR1-mutated breast cancer; being studied in uterine sarcomas. Sources: FDA label, NCI Thesaurus, Web Search.

Key Inclusion

  • Histologically confirmed uterine sarcoma (uLMS, ESS, adenosarcoma, or PEComa)
  • ER expression ≥75% of tumor cells by immunohistochemistry
  • Locally advanced or metastatic disease not amenable to surgery
  • Measurable disease ≥10 mm by CT/MRI or ≥20 mm by chest x-ray
  • Age ≥18 years
  • ECOG performance status ≤2
  • Adequate organ and marrow function
  • Postmenopausal or on GnRH agonist with adequate contraception

Key Exclusion

  • Receiving other investigational agents
  • Allergic reactions to elacestrant or similar compounds
  • Rapidly progressive symptomatic visceral disease
  • Uncontrolled intercurrent illness or active infection
  • Treatment with strong CYP3A inducers/inhibitors within 2 weeks
  • Pregnant or nursing
  • QTc interval ≥450 msec
  • Psychiatric illness limiting compliance

NCT07290309

Efficacy of a Group-based Videoconference Intervention to Increase Physical Activity in Cancer Survivors

Organization/Sponsor: Colorado State University


Example patient: A 58-year-old English-speaking woman with ovarian cancer who completed chemotherapy 6 months ago, currently on maintenance olaparib, sedentary with controlled blood pressure, seeking to increase physical activity.

Phase N/A

Interventions

  • Behavioral: Asynchronous Group
    Summary: Pre-recorded exercise videos providing aerobic and strength exercises with remote monitoring for cancer patients to improve physical fitness and health outcomes (Summary of Web Search).
  • Behavioral: Virtually Supervised Exercise Sessions
    Summary: Live online group exercise classes aimed at reducing fatigue and improving fitness and quality of life in cancer patients (Summary of Web Search).

Key Inclusion

  • Able to speak/read English
  • Diagnosed with any type of cancer within the last 5 years
  • Completed primary or adjuvant treatment (chemotherapy, radiation, surgery)
  • No planned treatment within the next nine months
  • Long-term therapies such as anti-hormone or targeted therapies allowed

Key Exclusion

  • Existing participation in ≥150 minutes per week of moderate intensity aerobic exercise
  • Uncontrolled hypertension
  • Inability to walk without an assistive device
  • Current or planned participation in another structured exercise program

NCT07090109

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

Organization/Sponsor: University of Kentucky


Example patient: A 58-year-old woman recently diagnosed with ovarian cancer who has not previously had multi-gene panel testing for hereditary cancer syndromes.

Phase N/A

Interventions

  • Behavioral: Genetic testing education video
    Summary: Educational videos using visual and verbal information to increase knowledge and rates of genetic testing in ovarian and endometrial cancer patients by improving understanding and awareness (Source: 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

NCT07360314

A Phase 1, 2-Part, Multicenter, Open-Label, First-in-Human Study of the Anti-Ly6E Exatecan Antibody-Drug Conjugate M7437 in Participants With Advanced Solid Tumors Genomic-based

Organization/Sponsor: EMD Serono


Example patient: A 58-year-old woman with metastatic epithelial ovarian cancer refractory to platinum-based chemotherapy, ECOG 1, with high Ly6E expression on tumor biopsy and adequate organ function.

Phase 1

Interventions

  • Drug: M7437
    Summary: M7437 is an antibody-drug conjugate targeting Ly6E with exatecan payload for advanced solid tumors with high Ly6E expression. Source: Summary of Web Search and trial title.

Key Inclusion

  • Histologically proven advanced solid tumors with known prevalent and high Ly6E expression
  • Unresectable locally advanced or metastatic solid tumor refractory to standard therapies
  • ECOG Performance Status ≤1
  • Adequate blood, liver, and kidney function
  • Tumor types: NSCLC, triple-negative breast cancer, head and neck squamous cell carcinoma, pancreatic ductal adenocarcinoma, gastric cancer, epithelial ovarian cancer
  • Prior lines of therapy received for tumor type

Key Exclusion

  • History of another malignancy within 3 years before enrollment with exceptions
  • Known brain metastases unless treated, stable for ≥4 weeks, and no neurological symptoms
  • Diarrhea or ileus Grade >1 within 1 week of Cycle 1 Day 1
  • Active chronic inflammatory bowel disease and/or bowel obstruction
  • History of serious gastrointestinal bleeding within 3 months of Cycle 1 Day 1
  • History of hematopoietic allogenic transplantation

NCT07318558

A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102) Genomic-based

Organization/Sponsor: Merck Sharp & Dohme LLC


Example patient: A 58-year-old woman with newly diagnosed stage IIIC high-grade serous ovarian cancer, HRD-negative, who completed optimal debulking surgery and six cycles of carboplatin-paclitaxel chemotherapy with complete response.

Phase 3

Interventions

  • Drug: Sacituzumab tirumotecan
    Summary: Sacituzumab tirumotecan is an antibody-drug conjugate targeting TROP2-expressing cancer cells, delivering a cytotoxic payload directly to tumor cells, showing antitumor activity in ovarian and endometrial cancers (Summary of Web Search).
  • Biological: Bevacizumab
    Summary: Bevacizumab is a recombinant humanized monoclonal antibody that inhibits VEGF to block tumor angiogenesis, preventing new blood vessel formation required for tumor growth, indicated for ovarian cancer among others (FDA label, NCI Thesaurus).
  • Other: Rescue Medications
    Summary: Medicinal products administered when investigational product efficacy is unsatisfactory, effects are excessive causing patient hazard, or to manage emergency situations (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma
  • Completed primary or interval debulking surgery
  • Completed first-line platinum-based chemotherapy with stable disease, partial response, complete response, or no evidence of disease
  • Provided tumor tissue not previously irradiated
  • HRD-negative tumor status as determined by central laboratory

Key Exclusion

  • Nonepithelial cancers, low-grade serous or endometrioid tumors, borderline tumors, mucinous, malignant Brenner's tumor, undifferentiated carcinoma
  • Known active CNS metastases or carcinomatous meningitis
  • History of severe eye disease
  • Active inflammatory bowel disease requiring immunosuppressive medication
  • History of noninfectious pneumonitis or interstitial lung disease requiring steroids
  • Prior systemic anticancer therapy except required first-line platinum-based chemotherapy
  • HRD-positive, unknown, or inconclusive tumor status
  • Active or ongoing stomatitis of any grade

NCT07211659

A Phase I, Open-label, Dose Finding, Safety, Tolerability and Exploratory Trial of THEO-260 Administered Via an Intraperitoneal Route in Patients With High Grade Serous or Endometrioid Ovarian Cancer

Organization/Sponsor: Theolytics Limited


Example patient: A 58-year-old postmenopausal woman with platinum-resistant high-grade serous ovarian cancer progressing 4 months after last platinum therapy, ECOG 1, with measurable peritoneal disease and no CNS involvement.

Phase I

Interventions

  • Investigational Product: THEO-260
    Summary: THEO-260 is a targeted intervention administered intraperitoneally, designed to specifically kill ovarian cancer cells; mechanism not publicly disclosed (Web Search).

Key Inclusion

  • Advanced high grade serous or endometrioid cancer of fallopian tube, primary peritoneum, or ovary
  • Platinum-resistant or refractory disease (progression within 6 months of last platinum cycle or during first 3 months)
  • Life expectancy >6 months
  • ECOG performance status 0 or 1
  • Measurable disease per RECIST V1.1
  • Adequate haematological and organ function

Key Exclusion

  • Prior anti-cancer treatment within 28 days or 5 half-lives
  • Prior treatment with group B adenovirus
  • Clinical evidence of cerebral metastases or CNS involvement
  • Prior pneumonitis or interstitial lung disease
  • Active hepatitis B, hepatitis C, HIV, tuberculosis, or SARS-CoV-2 infection
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • LVEF <45% or myocardial infarction within 6 months
  • Arterial oxygen saturation <92% on room air