Trials / Terminated

TerminatedNCT06865677

Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

Phase II Pilot Study of Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

Status: Terminated
Phase: Phase 2
Study type: Interventional
Enrollment: 2 (actual)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: Female
Age: 18 Years – 120 Years
Healthy volunteers: Not accepted

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...

Detailed description

Background: * Human trophoblast cell-surface marker (TROP2) is a surface glycoprotein originally identified in human placental tissue and highly expressed in gynecologic malignancies. TROP2 overexpression in ovarian, endometrial, and cervical cancers is linked to tumorigenicity and poor overall survival. * Sacituzumab govitecan (SG) is an antibody-drug conjugate (ADC) of an Immunoglobulin G (IgG(kappa)1 monoclonal antibody targeting TROP2 with a chemotherapeutic payload of SN-38. SN-38 is an active metabolite of irinotecan and acts as a topoisomerase I inhibitor. * Preclinical data suggest that SG induces deoxyribonucleic acid (DNA) damage, replication stress, and tumor shrinkage in drug-resistant ovarian, endometrial, and cervical cancer in vitro and in vivo preclinical models. * Further clinical and translational studies are needed to better understand SGs clinical activity and biology in relapsed gynecologic cancer patients. Objective: -To determine the objective response rate (ORR) of sacituzumab govitecan (SG) in participants with recurrent gynecological malignancies, calculated for each individual tumor histology by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Eligibility: * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status \<= 1 * Histologically documented, recurrent platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancer (referred to as ovarian cancer); recurrent endometrioid or serous endometrial cancer; or recurrent epithelial cervical cancer * At least two prior systemic therapeutic regimens * Measurable disease by RECIST v1.1 criteria with lesions that can be safely biopsied * No prior TROP2-targeting antibody drug conjugates (ADC) Design: * This is an open label, non-randomized Phase II pilot study with one Arm. * SG will be administered intravenously (IV) at 10 mg/kg on Days 1 and 8 each 21-day cycle. * Tumor assessments will be time-based: every 9 weeks (+/- 1 week) for the first year and every 12 weeks (+/- 1 week) thereafter until disease progression. Pre-treatment biopsies and serial blood samples will be collected for the correlative studies. * Treatment will be given for a maximum of 5 years or until disease progression or unacceptable toxicities. * Up to 66 evaluable participants will be enrolled.

Conditions

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan	10mg/kg administered intravenous (IV) infusion on days 1 and 8 of each 21-day cycle.
DIAGNOSTIC_TEST	EKG	Screening.
DIAGNOSTIC_TEST	Brain MRI	Screening. Baseline/Cycle 1 Day 1 (within 14 (+3) days.
DIAGNOSTIC_TEST	CT scans	Screening. Baseline/Cycle 1 Day 1 (within 14 (+3) days. Subsequent cycle 3 every 3 cycles ±7 days for the first year and then every 4 cycles ±7 days until progressive disease or up to 5 years. End of treatment assessments +14 days.
PROCEDURE	Tumor biopsy	Baseline/Cycle 1 Day 1≤10 days. End of treatment assessments +14 days (optional).
DRUG	Loperamide	For diarrhea. 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily.
DRUG	Octreotide	For diarrhea. 100-150 mcg subcutaneous (SC) three times a day if diarrhea persists.
DRUG	Diphenoxylate/Atropine	For diarrhea. 20 mg of diphenoxylate/atropine (Lomotil) administered according to package insert guidelines.
DRUG	Antiemetics	For vomiting as clinically indicated.

Timeline

Start date: 2025-06-09
Primary completion: 2025-07-01
Completion: 2025-07-01
First posted: 2025-03-10
Last updated: 2026-01-21
Results posted: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06865677. Inclusion in this directory is not an endorsement.