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Active Not RecruitingNCT04251416

A Study of Sacituzumab Govitecan (IMMU-132) in Endometrial Carcinoma

A Phase II Evaluation of Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2-SN-38 Antibody-drug Conjugate, in Patients With Persistent or Recurrent Endometrial Carcinoma

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Yale University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132) in subjects with persistent or recurrent endometrial carcinoma.

Detailed description

This is an open-label, Phase 2 study designed to assess the clinical activity of sacituzumab govitecan in subjects with persistent or recurrent endometrial carcinoma.

Conditions

Interventions

TypeNameDescription
DRUGSacituzumab GovitecanSacituzumab govitecan will be administered at 10 mg/kg weekly as an infusion for 2 consecutive weeks (2 weekly doses plus 1 week without treatment represents a single 3 week cycle). Treatment can be continued without a rest period in the absence of progression of disease or unacceptable toxicity.

Timeline

Start date
2020-03-17
Primary completion
2026-12-01
Completion
2027-02-01
First posted
2020-01-31
Last updated
2026-02-17

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04251416. Inclusion in this directory is not an endorsement.