drugset / Trial / NCT06865677

Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

NCT06865677

Phase 2 Terminated 2 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

Background: Cancers of the female reproductive organs often come back after treatment. A drug called sacituzumab govitecan (SG) has been approved for use in other types of cancers. Researchers want to see if SG can also help people with ovarian, endometrial, or cervical cancers. Objective: To test SG in people with ovarian, endometrial, or cervical cancers. Eligibility: People aged 18 years and older with ovarian, endometrial, or cervical cancer. Their cancers must have returned after at least 2 rounds of standard treatments. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and a test of their heart function. They also will have biopsies to get new tissues samples taken from their tumors. SG is infused through a tube attached to a needle inserted into a vein in the arm. Treatment will be given in 21-day cycles. Participants will receive SG on days 1 and 8 of each cycle. Each infusion takes 1 to 3 hours. Participants may receive SG for up to 5 years. They can continue as long as the drug is helping them. Imaging scans and other tests will be repeated throughout the study period. Participants will have an end-of-treatment visit within 2 weeks and a safety visit about 30 days after they stop treatment. Physical exams, blood tests, and imaging scans may be repeated. Participants will then be contacted by phone every 6 months for up to 10 years after their first dose of SG. Sponsoring Institution: National Cancer Institute...

Timeline

Start
2025-06-09
Primary completion
2025-07-01
Completion
2025-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sacituzumab Govitecan Monoclonal antibody 10 mg/kg Intravenous
Background Diphenoxylate/Atropine Unknown 20 mg
Background Loperamide Small molecule 2 mg
Background Octreotide Peptide 100 ug Subcutaneous
Background Octreotide Peptide 150 ug Subcutaneous