NCT06028932

A Study of Sacituzumab Govitecan (IMMU-132) in Platinum-resistant Ovarian Cancer Patients

A Phase II Evaluation of Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2-SN-38 Antibody-drug Conjugate in Recurrent or Persistent Platinum-resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (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 recurrent or persistent platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancers.

Detailed description

This is an open-label, Phase 2 study designed to assess the clinical activity of sacituzumab govitecan in subjects with recurrent or persistent platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancers.

Conditions

• Ovarian Carcinoma

Interventions

Type	Name	Description
DRUG	Sacituzumab govitecan	Sacituzumab 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: 2024-01-08
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2023-09-08
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study