RecruitingPhase 1Phase 2NCT06040970

Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer

A Single-Center, Open-Label, Single-Arm, Phase I Study With Dose Expansion Cohort of Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

54 participants

Start Date

Oct 23, 2024

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Malignant Neoplasm of Uterus

Summary

This is an open-label, Phase 1 study with a dose expansion cohort of Sacituzumab Govitecan in Combination with Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer. The goal of the study is to determine the optimal dose of sacituzumab govitecan for use in combination with cisplatin for treatment of epithelial ovarian and endometrial cancers.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — sacituzumab govitecan (a targeted cancer drug) and cisplatin (a chemotherapy drug) — to treat ovarian or uterine (endometrial) cancer that has come back more than 6 months after platinum-based chemotherapy. **You may be eligible if...** - You are a woman aged 18 or older with confirmed ovarian cancer or endometrial (uterine) cancer - Your cancer came back more than 6 months after your last platinum-based chemotherapy (called platinum-sensitive) - You are in generally good health with a life expectancy of at least 12 weeks - Your cancer is measurable on scans **You may NOT be eligible if...** - Your cancer came back less than 6 months after platinum chemotherapy - You have serious organ dysfunction or active infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab

Dose 0: Sacituzumab govitecan 7.5 mg/kg Dose -1: Sacituzumab govitecan 5 mg/kg

DRUGCisplatin

Cisplatin 70 mg/m2 IV

Locations(1)

Icahn School of Medicine at Mount Sinai Division of Hematology and Medical Oncology

New York, New York, United States

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NCT06040970

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