Clinical Trials for Ovarian Cancer

A Multicenter Phase 1/2a, Open-Label Study of SQ3370 in Patients With Advanced Solid Tumors

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.

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.

HealthScout AI summary: Adults with advanced solid tumors eligible for anthracyclines and with at least one injectable lesion, including expansion cohorts for unresectable/metastatic soft tissue sarcoma (anthracycline‑naïve) and relapsed/metastatic HNSCC after ≤2 prior regimens. Treatment is SQ3370, a locally activated doxorubicin platform using intratumoral SQL70 biopolymer and IV SQP33 protodrug that releases native doxorubicin at the injected tumor via bioorthogonal click chemistry to enhance local exposure and limit systemic toxicity.

ClinicalTrials.gov ID: NCT04106492

Palbociclib and Binimetinib in RAS-Mutant Cancers: A ComboMATCH Treatment Trial

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.

HealthScout AI summary: Adults with measurable, unresectable/metastatic tumors harboring KRAS/NRAS/HRAS mutations or non–BRAF V600E MAPK-pathway alterations (with dedicated cohorts for MEK-naive LGSOC, MEK-pretreated LGSOC, pancreatic cancer post ≥1 line, and other solid tumors per ComboMATCH) receive palbociclib (CDK4/6 inhibitor) plus binimetinib (MEK1/2 inhibitor), with a randomized comparison to binimetinib alone in MEK-naive LGSOC. Key exclusions include RB1 loss and BRAF V600E; crossover to combination is allowed at progression in the LGSOC randomized cohort.

ClinicalTrials.gov ID: NCT05554367

A Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies

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.

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.

HealthScout AI summary: Adults with MUC16-positive advanced ovarian, primary peritoneal/fallopian tube, or endometrial cancer after prior platinum (and prior anti–PD‑1 for endometrial) receive the investigational MUC16×CD28 costimulatory bispecific REGN5668 alone or combined with anti–PD‑1 cemiplimab, cemiplimab+anti–LAG‑3 fianlimab, or the MUC16×CD3 T‑cell engager ubamatamab (some cohorts with IL‑6R blocker sarilumab for CRS mitigation). Aims to enhance T‑cell activation against MUC16 tumors via CD28 costimulation with or without PD‑1/LAG‑3 blockade or CD3 engagement; key exclusions include prior MUC16‑targeted therapy, active autoimmune/CNS disease, and significant cardiac disease.

ClinicalTrials.gov ID: NCT04590326

An Open Label Phase II Study of the Efficacy and Safety of Abemaciclib, a Cyclin Dependent Kinase (CDK4/6) Inhibitor in Selected Patients With Recurrent Ovarian or Endometrial Cancer

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to 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.

HealthScout AI summary: Biomarker-selected adults with recurrent ovarian (including fallopian tube/primary peritoneal) or endometrial cancer receive abemaciclib, a CDK4/6 inhibitor targeting cyclin D–CDK4/6–RB signaling; ovarian cases require CDK4/6 pathway activation, and endometrioid endometrial tumors must be HR-positive without CCNE amplification or RB loss. Hormone receptor–positive tumors may also receive an aromatase inhibitor (anastrozole or letrozole).

ClinicalTrials.gov ID: NCT04469764

A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer

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.

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.

HealthScout AI summary: Adults with advanced/metastatic CLDN6-positive solid tumors (e.g., ovarian, endometrial, testicular, subsets of NSCLC) receive TORL-1-23 monotherapy, an anti-CLDN6 antibody–drug conjugate delivering MMAE via a cleavable linker, in dose-escalation with tumor-specific expansions. Eligible patients have ECOG 0–1 and adequate organ function; key exclusions include active/symptomatic CNS disease and uncontrolled comorbidities.

ClinicalTrials.gov ID: NCT05103683

A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers

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.

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.

HealthScout AI summary: Adults with recurrent epithelial ovarian, primary peritoneal, fallopian tube, or other MUC16-positive cancers (including MUC16+ endometrial) after prior platinum therapy and without standard options; a randomized cohort targets platinum‑resistant ovarian cancer after 2–4 prior lines. Investigational therapy is ubamatamab, a MUC16×CD3 T cell–engaging bispecific antibody, given IV as monotherapy or combined with the anti–PD‑1 antibody cemiplimab.

ClinicalTrials.gov ID: NCT03564340

Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a TCR Recognizing a Cancer/Germline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and/or Refractory Solid Tumors

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.

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.

HealthScout AI summary: Adults with PRAME-expressing, recurrent/refractory solid tumors (HLA‑A*02:01+, ECOG 0–1) receive autologous PRAME‑specific TCR‑T therapy (IMA203 or IMA203CD8) after cyclophosphamide/fludarabine lymphodepletion, with low‑dose IL‑2 support and an arm combining IMA203 with nivolumab. IMA203 targets a PRAME peptide via engineered TCR, while IMA203CD8 co‑expresses CD8αβ to enable CD4/CD8 T‑cell tumor killing; nivolumab (PD‑1 inhibitor) is tested for potential synergy.

ClinicalTrials.gov ID: NCT03686124

A Randomized Trial of Selumetinib and Olaparib or Selumetinib Alone in Patients With Recurrent or Persistent RAS Pathway Mutant Ovarian and Endometrial Cancers: A ComboMATCH Treatment Trial

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.

HealthScout AI summary: Adults with recurrent/persistent RAS-pathway–mutant ovarian, fallopian tube, primary peritoneal, or endometrial cancers (KRAS/NRAS/HRAS/BRAF/MEK1/MEK2 activating or NF1 loss), measurable and biopsiable, are randomized to selumetinib (MEK1/2 inhibitor) plus olaparib (PARP inhibitor) versus selumetinib alone; ovarian patients must be platinum-ineligible and endometrial patients should have received or been offered immunotherapy (± lenvatinib). No prior MEK inhibitors or progression on PARP allowed; crossover to the combination is permitted at progression from selumetinib monotherapy.

ClinicalTrials.gov ID: NCT05554328

A Randomized Phase 2 Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Patients With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression

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.

HealthScout AI summary: Adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer with high FRα expression (≥75% cells ≥2+ by VENTANA FOLR1), both platinum-sensitive and -resistant (not primary refractory), receive mirvetuximab soravtansine (FRα-targeted antibody–drug conjugate delivering DM4) IV q3w. Patients are randomized to ocular AE prophylaxis with prednisolone acetate eye drops vs brimonidine, with serial ophthalmic assessments; key exclusions include significant ocular disease, >Grade 1 neuropathy, prior FRα therapy, and poor baseline vision.

ClinicalTrials.gov ID: NCT06365853

REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) Versus Investigator's Choice (IC) Chemotherapy in Women With Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)

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.

HealthScout AI summary: Adults with relapsed, platinum-resistant high-grade serous ovarian, fallopian tube, or primary peritoneal cancer with centrally confirmed FOLR1 expression (ECOG 0–1; 1–3 prior lines, bevacizumab if available) are randomized to the FOLR1-targeted antibody–drug conjugate luveltamab tazevibulin (delivering a tubulin-inhibiting payload) versus investigator’s choice of single-agent chemotherapy (gemcitabine, weekly paclitaxel, PLD, or topotecan). Key exclusions include non–high-grade serous histology, prior FOLR1 ADCs or tubulin-ADC exposure, primary platinum-refractory disease, significant ocular/pulmonary/cardiac/CNS comorbidities, and solid organ transplant.

ClinicalTrials.gov ID: NCT05870748