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A Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With Bevacizumab in Epithelial Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:
A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With Bevacizumab in Patients With Advanced Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers)

Clinical Trial Summary

Phase 1 trial to study the safety, pharmacokinetic and Preliminary Efficacy of STRO-002 in combination with Bevacizumab.

Clinical Trial Description

This study is a Phase 1, open-label, multicenter, dose escalation study to assess preliminary efficacy for STRO-002 combined with bevacizumab in patients with advanced ovarian cancer that is refractory or has relapsed after standard available therapy. Fallopian tube and primary peritoneal cancers are treated in the same manner as epithelial ovarian cancers and are thus included in this study. The dosing regimen will include bevacizumab administered at the labeled dose of 15 mg/kg IV q 3 weeks given together with STRO-002 at increasing dose levels administered IV q 3 weeks. The RP2D of STRO-002 given with bevacizumab 15 mg/kg q 3 weeks will be determined by dose escalation. Dose expansion will enroll approximately 40 subjects with advanced relapsed ovarian cancer treated with STRO-002 plus bevacizumab at the RP2D determined in dose escalation. Subjects in the dose expansion portion of the study will be required at screening to submit both archival tumor tissue (if available and available tissue has adequate tumor) and tumor tissue from a biopsy done during screening to the central laboratory for analysis of FOLRα expression, both prior to enrollment in the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05200364
Study type Interventional
Source Sutro Biopharma, Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date March 22, 2022
Completion date January 2026
View Details
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