GYN Clinical Trials

GYN

22067- Phase 1/2 Study of PRO1184 in Patients with Locally Advanced and/or Metastatic Solid Tumors: Breast Endometrial Ovarian Lung Mesothelioma – 22067- (PRO1184-001) NCT:05579366 COHORTS FOR: PROC, PSOC, PROC/PSOC

• Phase – 1/2
• Stage(s) – III, IV
• Line of Therapy – 1-3 lines
• Investigational Drug – PRO1184
• Drug Class – ADC
• Mechanism of Action – folate receptor alpha (FRα) targeted antibody-drug conjugate
• Biomarker(s) – cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer, breast cancer (hormone receptor-positive, HER2-negative, and triple-negative), mesothelioma
• Sponsor – Provision for Medicine; Profound BIO

24030- A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy (GS-US-682-6769)

• Phase – 3
• Stage(s) – Recurrent/persistent endometrial cancer (carcinoma or carcinosarcoma)
• Line of Therapy – can have up to 3 lines (platinum, anti-PD-1/PD-L1)
• Investigational Drug – Sacituzumab Govitecan
• Mechanism of Action – The humanized monoclonal antibody hRS7 IgG1κ, which binds to trophoblast cell-surface antigen 2 (Trop-2), a transmembrane calcium signal transducer that is overexpressed in many epithelial cancers

22242- A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER TRIAL OF SELINEXOR IN MAINTENANCE THERAPY AFTER SYSTEMIC THERAPY FOR PATIENTS WITH P53 WILD-TYPE, ADVANCED OR RECURRENT ENDOMETRIAL CARCINOMA (ENGOT-EN-20/GOG-3083/ XPORT-EC-042)

• Phase – 3
• Stage(s) /Line of Therapy – completed at least 12 weeks of platinum therapy for Primary stage IV or first relapse
• Investigational Drug – Selinexor
• Mechanism of Action – a selective inhibitor of the nuclear export compound that binds and inactivates exportin 1 (XPO1). XPO1 is overexpressed in a large variety of malignancies. Inhibition of XPO1 by selinexor promotes apoptosis in malignant cells by blocking the above XPO1-mediated mechanisms.

21365- A Randomized Controlled Trial of Robotic versus Open Radical Hysterectomy for Cervical Cancer (ROCC trial)

• Phase – III
• Stage(s) – FIGO Stage IA2, IBI, IB2
• Investigational Drug – N/A – Surgical
• Sponsor – GOG Foundation, Inc.

24100- An Open-label, Multi-Center, Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib (PIKTOR) with Paclitaxel, and a Substudy Evaluating PIKTOR with Paclitaxel plus an Insulin-Suppressing Diet, in Patients with Advanced or Recurrent Endometrial Cancer (FTH-PIK-201)

• Phase – II
• Stage(s) – Advanced/Recurrent
• Line of Therapy – Participant has received at least one but not more than three prior systemic therapies. Prior therapy must include platinum-based chemotherapy and a checkpoint inhibitor, separately or in combination
• Investigational Drug – PIKTOR
• Mechanism of Action – simultaneously inhibiting the PI3K/AKT/mTOR pathway
• Biomarker(s) – PI3K/AKT/mTOR pathway gene alteration
• Sponsor – FAETH Therapeutics, Inc

24112- A Phase 2 Study Evaluating The Efficacy And Safety Of TORL-1-23 In Women With Advanced Platinum Resistant Epithelial Ovarian Cancer (Including Primary Peritoneal And Fallopian Tube Cancers) Expressing Claudin 6 (CLND6) (TORL123-002)

• Phase – II
• Stage(s) – Advanced
• Line of Therapy – at least one but no more than three prior systemic lines of anticancer therapy (see protocol for more details)
• Investigational Drug – TORL-1-23
• Drug Class – ADC
• Mechanism of Action – TORL-1-23 is an ADC that targets CLDN6 and contains a MMAE payload
• Biomarker(s) – CLND6 (Claudin 6)
• Sponsor – TORL Biotherapeutics, LLC; TRIO Clinical Research