Clinical Trials for Ovarian Cancer

A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 (≥18; ≥15 for germ cell tumors) with CLDN6-positive advanced ovarian/fallopian tube/primary peritoneal cancer, endometrial adenocarcinoma, or germ cell tumors after standard therapy receive XmAb541, an investigational CLDN6×CD3 bispecific T‑cell–engaging antibody given IV or SC with step-up dosing. Excludes prior CLDN6-directed therapy, platinum-refractory ovarian cancer or rapid progression on ≥2nd-line, uncontrolled CNS metastases, active autoimmune disease, and significant comorbidities.

ClinicalTrials.gov ID: NCT06276491

Phase I Study of Talazoparib in Combination With Radiation Therapy for Locally Recurrent Gynecologic Cancers

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.

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 locally recurrent ovarian, fallopian tube, primary peritoneal, endometrial, cervical, or vaginal cancers confined to the abdomen/pelvis receive daily oral talazoparib, a PARP1/2 inhibitor and potent PARP trapper/radiosensitizer, starting before and during fractionated external-beam radiation. Eligible patients must have ECOG 0–1 (or adequate life expectancy), adequate organ function, and at least one non-previously-irradiated measurable lesion; prior RT to the planned field, carcinomatosis/ascites/hepatic metastases, or need for extended-field RT are excluded.

ClinicalTrials.gov ID: NCT03968406

Phase II Clinical Trial of PLX038 in Patients With Platinum-Resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

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.

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: Metastatic, platinum-resistant high-grade serous ovarian, fallopian tube, or primary peritoneal cancer (initially platinum-sensitive; ≤1 prior line for platinum-resistant disease; prior PARP allowed) treated with PLX038, a long-acting pegylated prodrug of SN-38 (topoisomerase I inhibitor) given IV every 21 days until progression/toxicity. Excludes non–HGS histology and patients with UGT1A1 deficiency (e.g., Gilbert’s or homozygous UGT1A1*28).

ClinicalTrials.gov ID: NCT05465941

A Phase 1 Study to Evaluate TAG72-Targeting Chimeric Antigen Receptor (CAR) T Cells in Patients With Advanced Epithelial Ovarian Cancer

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.

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 recurrent, platinum-resistant epithelial ovarian cancer whose tumors are TAG72-positive receive lymphodepleting fludarabine/cyclophosphamide followed by a single intraperitoneal infusion of autologous TAG72-directed CAR T cells. Investigational therapy targets the TAG72 glycoprotein to mediate CAR T–cell killing of peritoneal ovarian cancer; single-arm dose-escalation with long-term follow-up.

ClinicalTrials.gov ID: NCT05225363

Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)

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.

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: Single-arm study for adults with recurrent primary mucinous ovarian cancer (ECOG 0–2) undergoing secondary cytoreductive surgery followed by intraoperative HIPEC using cisplatin. Aims to improve progression-free survival with a locoregional approach (heat-enhanced, DNA crosslinking cytotoxic agent) while evaluating perioperative toxicity and quality of life.

ClinicalTrials.gov ID: NCT05123807

Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (post‑bevacizumab; BRCA‑mutated must have prior PARP inhibitor) receive outpatient lymphodepleting cyclophosphamide/fludarabine followed by three intraperitoneal doses of FT536, an off‑the‑shelf iPSC‑derived CAR NK product targeting the α3 domain of MICA/MICB with enhanced ADCC (high‑affinity non‑cleavable CD16), IL‑15/IL‑15Rα support, and CD38 knockout. Treatment is delivered via intraperitoneal catheter across dose‑escalation cohorts; patients must be fit for lymphodepletion and long‑term follow‑up for gene‑modified cell therapy.

ClinicalTrials.gov ID: NCT06342986

Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors (CAR) and Containing the Inducible Caspase 9 Safety Switch in Subjects With Recurrent Platinum Resistant Epithelial Ovarian Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 recurrent platinum-resistant or -refractory high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube carcinoma (ECOG 0–2) receive lymphodepleting cyclophosphamide/fludarabine followed by a single intraperitoneal infusion of autologous B7-H3 (CD276)–targeted CAR T cells incorporating an inducible caspase-9 safety switch (rimiducid-activatable). Single-arm dose-escalation with intraperitoneal port/catheter; serial biopsies required.

ClinicalTrials.gov ID: NCT06305299

A Phase 1a/b Study to Evaluate the Safety and Efficacy of OPB-101, an Autologous Mesothelin (MSLN) CAR T Cell Therapy With Antigen-dependent Expression of OUTSMART™ Designed IL-2 Cytokine in Platinum-resistant Ovarian Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Single-arm study in adults with platinum-resistant high-grade serous ovarian, fallopian tube, or primary peritoneal cancer (ECOG 0–1, measurable disease, ≥2 prior lines, PARPi if BRCA1/2+) receiving OPB-101, an autologous mesothelin-directed CAR T cell therapy with antigen-dependent OUTSMART IL-2/15 cytokine expression and an EGFR-based safety switch. Evaluates dose escalation/expansion to define safety and RP2D.

ClinicalTrials.gov ID: NCT07030907

A Phase I Clinical Trial of an Infusion of Autologous T Cells Genetically Engineered With a Chimeric Receptor to Target the Follicle-Stimulating Hormone Receptor in Patients With Recurrent Ovarian Cancer

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.

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 recurrent or persistent epithelial ovarian, fallopian tube, primary peritoneal, or select sex cord-stromal tumors (platinum-resistant/refractory after ≥1 platinum and ≥2 prior systemic regimens; measurable/detectable disease; ECOG 0–2) receive a single infusion of autologous T cells engineered with a chimeric endocrine receptor targeting FSHR, delivered intraperitoneally or intravenously across escalating dose levels. Investigational product: FSHR-targeted CAR-like T cells designed for antigen-directed activation/cytotoxicity against FSHR-expressing tumors.

ClinicalTrials.gov ID: NCT05316129

The Efficacy of T-regulatory Cell Depletion with E7777 Combined with Immune Checkpoint Inhibitor, Pembrolizumab, in Recurrent or Metastatic Solid Tumors: Phase I/II Study

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.

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 recurrent/metastatic solid tumors that progressed on standard therapy (Phase I: pembrolizumab-appropriate tumors; expansion: platinum-resistant ovarian cancer without prior PD-1/PD-L1 and MSI-H cancers post–PD-1/PD-L1) receive pembrolizumab plus E7777 (denileukin diftitox), a CD25-directed IL-2–diphtheria toxin fusion that depletes T-regulatory cells. E7777 is given days 1–3 of 21-day cycles (dose-escalation to RP2D, up to 8 cycles) with fixed-dose pembrolizumab, continuing until progression/toxicity.

ClinicalTrials.gov ID: NCT05200559