Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

Stopped early · Phase 2

Conditions studied: Recurrent Platinum Resistant Epithelial Ovarian Carcinoma, Recurrent Epithelial Endometrial Carcinoma, Recurrent Epithelial Cervical Carcinoma

In brief

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...

Key facts

Study ID: NCT06865677
Run by: National Cancer Institute (NCI)
People needed: 2
Starts: 2025-06-09
Expected to finish: 2025-07-01
Last updated by the study team: 2026-01-21

Who can join

Age: 18 and older, up to 120. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

Participants who are receiving any other investigational agents
Primary platinum-refractory ovarian cancer (defined as progression while on the upfront platinum-based therapy)
Participants with any other concomitant invasive malignancies
History of severe hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to sacituzumab govitecan (SG), Camptosar; irinotecan; 7-ethyl-10-{4-[1-piperidino]-1-piperidino}carbonyoxycamptothecin (SN-38), or irinotecan.
Prior treatment with trophoblast cell-surface marker (TROP2)-targeting antibody drug conjugates (ADC). Participants with prior use of other ADCs are eligible.
Prior treatment with topoisomerase 1 inhibitors i.e., topotecan
Symptomatic or untreated brain/central nervous system (CNS) metastases
Participants who require treatment with uridine diphosphate glucuronosyltransferase (UGT1A1) inhibitors.
Participants with known homozygous UGT1A1*28 allele if tested during the previous treatment.
Participants with active infection requiring antibiotics.
Participants who have not recovered from toxicities or adverse events (AE) related to prior therapy to Grade <= 1 with the following exceptions.
Participants with platinum related hypomagnesemia (on replacement) are eligible.
Participants with auto-immune thyroid dysfunction on stable replacement therapy are eligible.
Participants with any grade alopecia or grade 1 or 2 neuropathy are eligible.
Participants with a history of gastrointestinal (GI) perforation or hemorrhage (> 30mL bleeding/episode) fistula or hemoptysis within 3 months prior to initiation of study therapy, intra-abdominal abscess in the 6 months prior to entry, history of ascites or pleural effusion requiring paracentesis or thoracentesis in the 4 weeks prior to initiation of study therapy or history of bowel obstruction within 3 months prior to initiation of study therapy.
Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during SG treatment or within 5 months after the final dose of SG. Note: Seasonal flu vaccines that do not contain a live virus and locally authorized/approved Coronavirus disease 2019 (COVID-19) vaccines are permitted
Participants with severe uncontrolled intercurrent illness that would limit compliance with study requirements, evaluated by history, physical exam, and chemistry panel.

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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