Clinical Trials for Ovarian Cancer

A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with platinum-resistant high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer (1–3 prior lines; prior bevacizumab and PARP inhibitor as indicated) are randomized to the CDH6-directed antibody-drug conjugate raludotatug deruxtecan (R-DXd; cleavable linker to DXd topoisomerase I payload) given IV q3w versus investigator’s choice of weekly paclitaxel, pegylated liposomal doxorubicin, gemcitabine, or topotecan. Requires measurable disease, ECOG 0–1, available tumor tissue; excludes prior CDH6/DXd ADCs and patients with active ILD/pneumonitis or significant uncontrolled comorbidities.

ClinicalTrials.gov ID: NCT06161025

A Randomised, Open-label, Phase III Study of AZD5335 Versus Mirvetuximab Soravtansine in FRα-high and AZD5335 Versus Investigator's Choice Chemotherapy in FRα-low Expressing High-grade Platinum-resistant Epithelial Ovarian Cancer Patients (TREVI-OC-01)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with high-grade serous epithelial ovarian/fallopian tube/primary peritoneal cancer with radiographic platinum-resistant relapse (progression >3 to ≤6 months after last platinum) after 1–3 prior systemic lines undergo central FRα testing and are enrolled into FRα-high or FRα-low cohorts. Patients are randomized to AZD5335 (torvutatug samrotecan), an FRα/FOLR1-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor payload, versus mirvetuximab soravtansine in FRα-high disease or versus investigator’s choice single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan) in FRα-low disease.

ClinicalTrials.gov ID: NCT07218809

A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with platinum-resistant, RECIST-measurable high-grade serous ovarian/fallopian tube/primary peritoneal cancer with CCNE1 (Cyclin E1) overexpression after 1–4 prior systemic lines (with prior bevacizumab and, if FRα-positive, prior mirvetuximab expected) are randomized to INCB123667, an oral selective CDK2 inhibitor targeting Cyclin E1–driven cell-cycle progression, versus investigator’s choice standard single-agent chemotherapy.

ClinicalTrials.gov ID: NCT07214779

A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L Platinum-Based Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with recurrent platinum-sensitive high-grade serous or endometrioid ovarian/fallopian tube/primary peritoneal cancer who have completed second-line platinum doublet chemotherapy and have CR/NED, PR, or stable disease (and BRCA-mut/HRD+ patients must have previously received 1L PARP maintenance) are randomized within 8 weeks to maintenance rinatabart sesutecan plus standard-of-care (bevacizumab maintenance if chosen or observation) versus standard-of-care alone. Rinatabart sesutecan is an FRα-targeted antibody–drug conjugate that delivers an intracellular topoisomerase I inhibitor payload to FRα-expressing tumor cells.

ClinicalTrials.gov ID: NCT07225270

A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This trial enrolls adults with recurrent or metastatic solid tumors—including endometrial, head and neck, pancreatic, colorectal, hepatocellular, gastric, urothelial, ovarian, cervical, biliary tract, certain subtypes of breast cancer, and cutaneous melanoma—whose disease has progressed after standard therapy and who have measurable, biopsiable disease. All patients receive ifinatamab deruxtecan, an investigational B7-H3-directed antibody-drug conjugate delivering a topoisomerase I inhibitor, administered intravenously every three weeks.

ClinicalTrials.gov ID: NCT06330064

Phase II Open-Label Multi-Cohort Study Evaluating CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Patients With Advanced Chemorefractory Colorectal, Pancreatic, or Other Solid Cancers

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Enrolling adults with advanced or metastatic colorectal, pancreatic, biliary, gastroesophageal, urothelial, ovarian, or non-small cell lung adenocarcinomas refractory to standard chemotherapy, this study combines the mitochondrial metabolism inhibitor devimistat (CPI-613) with hydroxychloroquine and either 5-FU or gemcitabine depending on tumor type. Eligible patients must have measurable disease and good performance status (ECOG 0-1, some 2 with approval).

ClinicalTrials.gov ID: NCT05733000

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with measurable, unresectable locally advanced or metastatic solid tumors that have progressed after standard therapies, enrolled in tumor-specific refractory cohorts (e.g., melanoma post–PD-(L)1, SCCHN post platinum/PD-(L)1, HER2-negative gastric/GEJ, HGS ovarian, cervical, endometrial, urothelial, ESCC, pancreatic, mCRPC, nonsquamous NSCLC without drivers, and HR+/HER2– breast cancer after CDK4/6 and chemo). Single-arm therapy is patritumab deruxtecan (HER3-DXd) 5.6 mg/kg IV q3w, an HER3-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor (DXd).

ClinicalTrials.gov ID: NCT06172478

RESOLVE: letRozole abEmaciclib combinationS in endOmetriaL and oVarian cancEr: A Multi-Cohort Phase 2 Study of Letrozole/Abemaciclib Alone and in Combination With Metformin, Zotatifin and Gedatolisib

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with recurrent/metastatic or treatment‑resistant endometrial cancer (primarily ER+) or low‑grade serous ovarian/fallopian tube/peritoneal carcinoma (ER+ preferred; ER‑ allowed in LGSOC) receive abemaciclib with letrozole, alone or combined with agents targeting PI3K/mTOR/DNA‑PK (samotolisib/LY3023414), pan‑class I PI3K/mTORC1/2 (gedatolisib), translational control via eIF4A (zotatifin), or metabolic/AMPK pathways (metformin). Most cohorts require ECOG 0–1, measurable disease, adequate organ function, and endocrine sensitivity markers; one cohort allows prior CDK4/6 inhibitor exposure.

ClinicalTrials.gov ID: NCT03675893

A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) Plus Defactinib (FAK Inhibitor) in Recurrent Gynecological Cancers (DURAFAK)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Enrolling adult women with recurrent/progressive gynecologic cancers (e.g., endometrioid, mucinous ovarian, high-grade serous ovarian, others) harboring MAPK-pathway alterations (RAS activation/mutation, BRAF class I–III mutation, and/or NF1 loss), ECOG 0–1, and prior systemic therapy; excludes prior RAF/MEK inhibitor exposure and LGSOC. Treatment is oral avutometinib (dual RAF/MEK “clamp”) plus defactinib (FAK inhibitor).

ClinicalTrials.gov ID: NCT05512208

A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Enrolling adult women with platinum‑resistant or refractory high‑grade serous ovarian, fallopian tube, or primary peritoneal cancer (measurable disease, ECOG 0–1) after at least one prior platinum regimen, randomized to CBX‑12 IV every 21 days at 100 vs 125 mg/m². CBX‑12 (alphalex exatecan) is a peptide–drug conjugate that targets acidic tumor microenvironments via pH‑low insertion peptide to deliver a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06315491