The goal of this clinical study is to find out how the study drug, sacituzumab govitecan (SG) works in participants with endometrial cancer who have received prior treatment with platinum-based chemotherapy and immunotherapy, versus the treatment of physician's choice (TPC). The primary objectives of this study are to evaluate the effect of SG compared to TPC on progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS).
Conditions: Endometrial Cancer
Eligibility Criteria
Inclusion Criteria
- Documented evidence of recurrent/persistent endometrial cancer (endometrial carcinoma or carcinosarcoma).
- Up to 3 prior lines of systemic therapy for endometrial cancer, including systemic platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, either in combination or separately.
- Eligible for treatment with either doxorubicin or paclitaxel as determined by the investigator.
- Radiologically evaluable disease (either measurable or nonmeasurable) by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1.
- Eastern Cooperative Oncology Group performance status score of 0 or 1.
- Adequate organ function
Exclusion Criteria
- Uterine leiomyosarcoma and endometrial stromal sarcomas are excluded.
- Participants who are candidates for curative-intent therapy at the time of study enrollment.
- Participants eligible for rechallenge with platinum-based chemotherapy as determined by the investigator.
- Received any prior treatment with a Trop-2-directed antibody-drug conjugate (ADC).
- Have an active second malignancy.
- Have an active serious infection requiring systemic antimicrobial therapy.
- Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months prior to randomization.
- Have a positive serum pregnancy test or are breastfeeding for participants who are assigned female at birth.
Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.