Sophic Logo gordian knotOvarian and Endometrial Cancer Clinical Trials Intelligence

Monthly Update Report - October 2025


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Important Notice:
Sophic does not practice medicine nor provide medical advice. 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. This report is not a substitute for professional medical advice, diagnosis, or treatment.

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


Overview

Number of Trials: 7

These seven trials investigate novel therapies for advanced solid tumors, with strong emphasis on gynecologic cancers (ovarian, endometrial, breast). Five trials focus on gynecologic malignancies, particularly platinum-resistant ovarian cancer and recurrent endometrial cancer. Experimental approaches include radioligand therapy (LY4337713), antibody-drug conjugates (LY4170156), small molecule degraders (ST-01156, RBM39), tyrosine kinase inhibitors (zanzalintinib), selective estrogen receptor degraders with CDK4/6 inhibitors (elacestrant plus abemaciclib), T-cell engagers (NRM-823), and oncolytic immunotherapy (THEO-260). Most trials enroll heavily pretreated patients who have progressed on standard therapies including platinum-based chemotherapy and checkpoint inhibitors.

Common Criteria Across Trials

Common Inclusion

  • ECOG performance status 0-1
  • Histologically or cytologically confirmed advanced or metastatic solid tumor
  • Measurable disease per RECIST v1.1
  • Adequate organ function (liver, renal, cardiac)
  • Adequate hematologic function (neutrophils, platelets, hemoglobin)
  • Prior systemic therapy required (1-3 prior lines typical)
  • Age ≥18 years
  • Life expectancy >6 months

Common Exclusion

  • Active or untreated CNS metastases or carcinomatous meningitis
  • Recent anticancer therapy within 2-4 weeks or 5 half-lives
  • Unresolved toxicities from prior therapy >Grade 1 (except alopecia, neuropathy)
  • Active uncontrolled infection requiring systemic treatment
  • Major surgery within 4-8 weeks
  • Significant cardiovascular disease or heart failure
  • QTc prolongation >470-480 ms
  • Prior pneumonitis or interstitial lung disease
  • Pregnancy or lactation
  • Active hepatitis B, C, or HIV (with exceptions for controlled HIV)

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


NCT07213791

A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)

Organization/Sponsor: Eli Lilly and Company


Example patient: A 58-year-old woman with platinum-resistant ovarian cancer showing FAP expression on imaging, ECOG PS 1, who progressed after two platinum-based chemotherapy regimens.

Phase 1

Interventions

  • Drug: LY4337713
    Summary: LY4337713 is an investigational radioligand therapy targeting fibroblast activation protein (FAP)-positive solid tumors. It aims to deliver targeted radiation to FAP-expressing cancer cells. Source: Summary of Web Search.

Key Inclusion

  • Clinical or imaging evidence of FAP expression
  • Histologically or cytologically confirmed adenocarcinoma of pancreas, HR-positive HER2-negative breast cancer, HER2-positive breast cancer, TNBC, platinum-resistant or refractory ovarian cancer, or other solid tumors
  • Prior treatment requirements vary by tumor type
  • ECOG performance status 0 to 1
  • Creatinine clearance ≥60 mL/min

Key Exclusion

  • Known active CNS metastases or carcinomatous meningitis
  • History of Grade 4 myelosuppression lasting >7 days or Grade 3 requiring >6 weeks recovery
  • Significant cardiovascular disease
  • QTcF >470 milliseconds
  • Previous hemi- or total-body radiation
  • Previous adoptive T-cell therapy (CAR-T, TCR therapy)
  • Unable to tolerate SPECT, PET, CT, or MRI

NCT07197554

A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies

Organization/Sponsor: SEED Therapeutics, Inc.


Example patient: A 52-year-old woman with metastatic ovarian cancer refractory to standard chemotherapy, ECOG performance status 1, with measurable peritoneal disease, adequate organ function, and no prior RBM39-targeted therapy.

Phase 1, Phase 1b

Interventions

  • Drug: ST-01156
    Summary: ST-01156 is a small molecule RBM39 degrader that targets the RBM39 splicing factor protein for degradation, modulating cellular RNA splicing responses in advanced solid tumors (Source: Summary of Web Search and trial title).

Key Inclusion

  • Age ≥18 years, or ≥16 years for Ewing Sarcoma or malignancies with biological rationale
  • Metastatic or locally advanced and unresectable solid tumor
  • At least 1 measurable lesion or evaluable disease per RECIST v1.1
  • ECOG performance status ≤2 at screening
  • Adequate organ function as defined in protocol

Key Exclusion

  • Received prior radiotherapy within 2 weeks of treatment
  • Known active CNS metastases and/or carcinomatous meningitis
  • Received anticancer therapy or investigational agent within 14 days or 5 half-lives
  • Major surgery within 28 days before study therapy
  • Unresolved toxicities from previous anticancer therapies except alopecia and peripheral neuropathy
  • Previously received a RBM39 inhibitor/degrader

NCT07213804

FRAmework-01: A Two-Part Phase 3 Study of LY4170156 Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and LY4170156 Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.

Organization/Sponsor: Eli Lilly and Company


Example patient: A 58-year-old woman with high-grade serous ovarian cancer who progressed 4 months after completing second-line platinum-based chemotherapy, has ECOG status 1, received prior bevacizumab and PARPi for BRCA mutation, and has measurable disease on CT scan.

Phase 3

Interventions

  • Antibody-Drug Conjugate: LY4170156
    Summary: An antibody-drug conjugate targeting folate receptor alpha (FRa) linked to exatecan, a topoisomerase I inhibitor. Upon binding FRa-expressing tumor cells, exatecan is released, inhibiting DNA replication and causing cell death with bystander effect. Source: NCI Thesaurus.
  • Chemotherapy: Paclitaxel
    Summary: A microtubule-stabilizing agent that inhibits cell division by preventing microtubule depolymerization, used in ovarian and endometrial cancer treatment. Source: Summary of Web Search.
  • Chemotherapy: Topotecan
    Summary: A topoisomerase I inhibitor that stabilizes topoisomerase I-DNA complexes, preventing DNA religation and producing lethal DNA breaks during replication. Indicated for recurrent cervical and small cell lung cancer. Source: FDA label, NCI Thesaurus.
  • Chemotherapy: Gemcitabine
    Summary: A nucleoside metabolic inhibitor that disrupts DNA synthesis by inhibiting ribonucleotide reductase and incorporating into DNA, causing masked termination. Indicated for pancreatic, lung, breast, and ovarian cancers. Source: FDA label, NCI Thesaurus.
  • Chemotherapy: Pegylated liposomal doxorubicin
    Summary: A liposome-encapsulated anthracycline that intercalates DNA and inhibits topoisomerase II, causing DNA breaks and apoptosis. Liposomal formulation improves tumor penetration and reduces cardiac toxicity. Source: FDA label, NCI Thesaurus.
  • Antibody-Drug Conjugate: MIRV
    Summary: An antibody-drug conjugate targeting folate receptor alpha, delivering a cytotoxic agent to ovarian cancer cells. FDA approved in 2023 for platinum-resistant ovarian cancer with improved survival outcomes. Source: Summary of Web Search.
  • Monoclonal Antibody: Bevacizumab
    Summary: A recombinant humanized monoclonal antibody that inhibits VEGF, blocking tumor angiogenesis by preventing new blood vessel formation. Indicated for multiple cancers including ovarian cancer, typically combined with chemotherapy. Source: FDA label, NCI Thesaurus.
  • Chemotherapy: Carboplatin
    Summary: A platinum-based agent that forms DNA cross-links, disrupting replication and inducing apoptosis. Indicated for advanced and recurrent ovarian carcinoma with similar efficacy to cisplatin but reduced toxicity. Source: FDA label, NCI Thesaurus.

Key Inclusion

  • Histologically confirmed high-grade serous ovarian, primary peritoneal, or fallopian tube cancer
  • Part A: Platinum-resistant disease (progression ≤6 months after last platinum therapy)
  • Part B: Platinum-sensitive disease (progression >6 months after last platinum therapy)
  • Part A: 1-3 prior lines of systemic cytotoxic therapy (up to 4 if one is mirvetuximab soravtansine)
  • Part B: 1-2 prior lines of systemic cytotoxic chemotherapy
  • Part B: Prior PARPi with progression on or within 6 months of completion
  • ECOG performance status 0-1
  • Measurable disease per RECIST v1.1

Key Exclusion

  • Prior antibody-drug conjugate with topoisomerase inhibitor payload
  • Part A: Primary platinum-refractory disease (progression ≤3 months since first-line platinum)
  • Part B: Clinically significant proteinuria

NCT06795009

Phase I/IB Study of Zanzalintinib in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer Genomic-based

Organization/Sponsor: Washington University School of Medicine


Example patient: A 62-year-old woman with recurrent grade 3 serous endometrial cancer, ECOG 1, who progressed on carboplatin/paclitaxel after one prior line of therapy, with measurable pelvic disease and controlled hypertension.

Phase 1

Interventions

  • Drug: Paclitaxel
    Summary: Paclitaxel is a microtubule inhibitor chemotherapy that binds tubulin, preventing spindle formation and disrupting cell division, inducing apoptosis in cancer cells. FDA-approved for ovarian, breast, lung cancers and Kaposi's sarcoma (FDA label, NCI Thesaurus).
  • Drug: Zanzalintinib
    Summary: Zanzalintinib is an oral multi-kinase inhibitor targeting c-Met, VEGFR2, AXL, and MER, blocking angiogenesis, tumor proliferation, invasion, and metastasis in overexpressing tumors (NCI Thesaurus).

Key Inclusion

  • Recurrent FIGO grade 3 endometrioid, serous, mixed high grade uterine/endometrial cancer or carcinosarcoma
  • Prior progression on platinum-based therapy or platinum intolerance
  • 1-2 prior lines of anti-cancer therapy allowed
  • Measurable disease by RECIST 1.1
  • ECOG performance status ≤2
  • Age ≥18 years
  • Adequate bone marrow and organ function
  • Recovery to baseline or ≤Grade 1 from prior treatment adverse events

Key Exclusion

  • Prior treatment with zanzalintinib, any tyrosine kinase inhibitor, or bevacizumab
  • Other malignancy within 2 years unless treated and disease-free
  • Concomitant oral anticoagulants (warfarin, direct thrombin inhibitors) or platelet inhibitors (clopidogrel)
  • Uncontrolled hypertension (BP >140/90 mmHg)
  • Cardiovascular events (stroke, MI, arterial thrombosis) within 6 months
  • GI disorders with high perforation/fistula risk or active inflammatory bowel disease
  • Major surgery within 8 weeks or incomplete wound healing
  • QTcF >480 ms on ECG

NCT07209449

Phase II Study of ELacestrant in Combination With Abemaciclib or Elacestrant Alone In p53 Wild Type, Estrogen Receptor-positive Advanced or recurrenT Endometrial Cancer (ELITE) Genomic-based

Organization/Sponsor: Memorial Sloan Kettering Cancer Center


Example patient: A 62-year-old postmenopausal woman with recurrent ER-positive, p53 wild-type endometrioid endometrial adenocarcinoma who previously received carboplatin-paclitaxel and pembrolizumab with disease progression, ECOG 1, no dMMR or POLE mutations, and adequate organ function.

Phase II

Interventions

  • Drug: Elacestrant
    Summary: Elacestrant is an oral selective estrogen receptor degrader (SERD) targeting ER-positive cancers, approved for metastatic breast cancer with ESR1 mutations after prior endocrine therapy progression (Web Search).
  • Drug: Abemaciclib
    Summary: Abemaciclib is an oral CDK4/6 inhibitor that arrests cell cycle in G1 phase by preventing retinoblastoma phosphorylation, FDA-approved for HR-positive, HER2-negative breast cancer in combination with endocrine therapy or as monotherapy (FDA label, NCI Thesaurus).

Key Inclusion

  • Age ≥18 years with ECOG performance status 0 or 1
  • Advanced or recurrent endometrial carcinoma refractory to curative therapy
  • ER-positive tumor (≥1% staining by IHC)
  • p53 wild type by IHC or TP53 wild type by NGS
  • No known dMMR or POLE mutation
  • Prior platinum-based chemotherapy and PD-1 inhibitor treatment
  • No more than 1 prior line of chemotherapy for endometrial carcinoma
  • No prior CDK4/6 inhibitor treatment

Key Exclusion

  • Prior treatment with elacestrant, other oral SERD, mTOR inhibitor, or CDK4/6 inhibitor
  • Visceral crisis, lymphangitic disease spread, or leptomeningeal carcinomatosis
  • Uncontrolled hyperlipidemia
  • History of interstitial lung disease or pneumonitis
  • Untreated or active CNS metastases requiring corticosteroids
  • Strong or moderate CYP3A4 inducers or inhibitors within 14 days
  • Major surgery within 4 weeks
  • Pregnant or nursing females

NCT07182149

A Phase 1a/1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors

Organization/Sponsor: Normunity AccelCo, Inc.


Example patient: A 58-year-old woman with metastatic ovarian adenocarcinoma, ECOG status 1, adequate organ function, no recent chemotherapy or checkpoint inhibitors, and no history of pneumonitis.

Phase 1

Interventions

  • Biological: NRM-823
    Summary: T-cell engager targeting a novel tumor-specific antigen in solid tumors including breast cancer, tested for safety and efficacy in Phase 1 trial (Source: Web Search).

Key Inclusion

  • Histologically or cytologically diagnosed NSCLC, TNBC, HNSCC, ESCC, esophageal adenocarcinoma, gastric/GEJ adenocarcinoma, cervical, endometrial, or ovarian cancer
  • Advanced or metastatic disease
  • ECOG Performance Status 0 or 1
  • Adequate liver, renal, pulmonary, and cardiac function
  • Adequate hematologic function

Key Exclusion

  • Cytotoxic chemotherapy, biologic agents, checkpoint inhibitors, or radiation therapy within 3 weeks or 5 half-lives prior to first dose
  • History of Grade 2 pneumonitis requiring steroids or any Grade 3-4 pneumonitis from prior therapy
  • Investigational therapy within 4 weeks or 5 half-lives prior to first dose
  • Unresolved toxicities from prior therapy greater than CTCAE Grade 1, except alopecia and Grade ≤2 neuropathy

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 adequate organ function.

Phase 1

Interventions

  • Biological: THEO-260
    Summary: THEO-260 is an oncolytic immunotherapy administered intraperitoneally that targets ovarian cancer cells by killing cancer cells and associated fibroblasts (Source: 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 3 months following first platinum dose)
  • 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 history of interstitial lung disease
  • Active hepatitis B or C, tuberculosis, SARS-CoV-2, or HIV 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