Clinical Trials for Ovarian Cancer

MC220601, Folate Receptor Alpha Dendritic Cells (FRαDCs) Plus Pembrolizumab for Patients With Advanced Stage Ovarian Cancer (FRAPPE)

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.

HealthScout AI summary: Adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (any platinum sensitivity; measurable and/or CA-125–evaluable disease; no prior PD‑1/PD‑L1) receive an autologous folate receptor alpha–loaded dendritic cell vaccine plus pembrolizumab. The FRαDC vaccine (monocyte-derived DCs pulsed with multi-epitope FRα peptides to enhance antigen presentation and T‑cell priming against FRα‑overexpressing tumors) is given intradermally alongside standard anti–PD‑1 therapy on a defined 21–42‑day schedule to assess safety and objective response.

ClinicalTrials.gov ID: NCT05920798

Randomized Phase I Study Assessing the Safety and Tolerability Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at Completion of Interval Cytoreductive Surgery Compared to Surgery and Chemotherapy Prior to Surgery for Patients With Stage III/IV Ovarian Cancer Undergoing Neoadjuvant Chemotherapy.

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.

HealthScout AI summary: Adults with newly diagnosed stage III–IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who responded to 3–4 cycles of neoadjuvant carboplatin/paclitaxel and are candidates for interval cytoreductive surgery are randomized to perioperative cisplatin either IV the day before surgery or as intraoperative HIPEC at the end of surgery. Compares safety/tolerability and feasibility of these cisplatin delivery strategies in the perioperative setting.

ClinicalTrials.gov ID: NCT05415709

Randomized Phase 2 Trial of APL-2 With Pembrolizumab vs. APL-2 With Pembrolizumab and Bevacizumab vs. Bevacizumab Alone in Patients With Recurrent Ovarian Cancer and Persistent Malignant Effusion

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.

HealthScout AI summary: Adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer and symptomatic malignant ascites/pleural effusion (ECOG 0–1; prior therapies and platinum sensitivity unrestricted) are randomized to pegcetacoplan (C3 complement inhibitor) plus pembrolizumab with or without bevacizumab versus bevacizumab alone. Aims include reducing effusion burden and assessing antitumor activity; key exclusions include active autoimmune disease requiring treatment, recent immunosuppression, recent checkpoint inhibitor, uncontrolled CV disease, and active HBV/HCV viremia.

ClinicalTrials.gov ID: NCT04919629

Efficacy of Oral Regorafenib Combined With Intra-muscular Injection of Fulvestrant in Patients With Recurrent Low-grade Serous Ovarian Cancer: A Phase II Single Arm 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.

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 low-grade serous ovarian cancer (measurable disease, ECOG 0–2; up to 5 prior lines; no prior regorafenib or multi-kinase TKIs; limited prior anti-angiogenic therapy) receive regorafenib (oral multikinase inhibitor of VEGFR/PDGFR/FGFR/RAF; ReDOS ramp-up, 3 weeks on/1 week off) plus intramuscular fulvestrant 500 mg (SERD). Aims to assess early objective response and survival/clinical benefit, with safety monitoring and exploratory genomic correlates.

ClinicalTrials.gov ID: NCT05113368

A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other 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.

HealthScout AI summary: This trial involves patients with advanced or metastatic solid tumors expressing Nectin-4, including urothelial carcinoma, triple-negative breast cancer, non-small cell lung cancer, and ovarian cancer, who have exhausted standard therapy options. It evaluates LY4052031, an antibody-drug conjugate that targets Nectin-4 to deliver a topoisomerase I inhibitor, aiming to assess its safety, tolerability, and efficacy in these patients.

ClinicalTrials.gov ID: NCT06465069

A First-in-human Dose Escalation and Optimization Phase I/IIa Study to Investigate Safety, Tolerability, PK, and Efficacy of the NaPi2b ADC TUB-040 in Patients With Platinum-resistant High-grade Ovarian Cancer (PROC) or r/r Adenocarcinoma Non-small Cell Lung Cancer (NSCLC)

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.

HealthScout AI summary: The trial involves patients with platinum-resistant high-grade ovarian cancer or relapsed/refractory non-small cell lung cancer, assessing the safety and efficacy of TUB-040, an antibody-drug conjugate targeting NaPi2b with a topoisomerase I inhibitor, administered every three weeks.

ClinicalTrials.gov ID: NCT06303505

A Phase 1, Open-label, Dose Escalation and Dose Expansion Study for LNCB74, a B7-H4 Targeted Antibody Drug Conjugate, as Monotherapy in Participants With 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.

HealthScout AI summary: This trial investigates LNCB74, a B7-H4 targeted antibody-drug conjugate, as monotherapy for adults with advanced, unresectable, or metastatic solid tumors that express B7-H4, aiming to evaluate its safety, tolerability, and efficacy. Participants must have measurable disease, an ECOG performance status of 0-1, and adequate organ function.

ClinicalTrials.gov ID: NCT06774963

Phase I/II First-in-Human Study of TT-10 (PORT-6), an Adenosine 2A Receptor Antagonist, and PORT-7, an Adenosine 2B Receptor Antagonist, as Single Agents and in Combination in Participants With Advanced Selected 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.

HealthScout AI summary: This trial enrolls patients aged 18 and older with advanced solid tumors, including RCC, CRPC, NSCLC, SCCHN, CRC, endometrial, and ovarian cancers, who have failed or are ineligible for standard treatments, to evaluate TT-10, an adenosine A2A receptor antagonist, and TT-4, an adenosine A2B receptor antagonist, administered as single agents and in combination.

ClinicalTrials.gov ID: NCT04969315

A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic 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.

HealthScout AI summary: Eligible patients are adults with advanced or metastatic solid tumors—including urothelial, triple negative breast, non-small cell lung, esophageal, pancreatic, ovarian, cervical (squamous), head and neck squamous cell, and prostate cancers—who have exhausted standard therapies and have ECOG 0–1. All participants receive intravenous LY4101174, a novel antibody-drug conjugate targeting nectin-4 and delivering a topoisomerase I inhibitor (exatecan).

ClinicalTrials.gov ID: NCT06238479

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Oncogene Amplifications

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.

HealthScout AI summary: Adults with locally advanced or metastatic solid tumors harboring oncogene amplifications who have progressed on or are ineligible for standard therapies may receive oral BBI-355, a selective CHK1 inhibitor, either as monotherapy or combined with erlotinib (EGFR inhibitor) or futibatinib (FGFR inhibitor) in cohorts defined by specific gene amplifications. Key exclusions include certain oncogenic mutations, prior targeted therapies, CNS involvement, and serious comorbidities.

ClinicalTrials.gov ID: NCT05827614