REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1

Active:	Yes
Cancer Type:	Gynecologic Cancers Ovarian Cancer Primary Peritoneal Cancer Unknown Primary	NCT ID:	NCT05870748
Trial Phases:	Phase II Phase III	Protocol IDs:	STRO-002-GM3 (primary) NCI-2023-04597 APGOT-OV9 ENGOT-OV79 GEICO-134-O GOG-3086
Eligibility:	18 Years and older, Female	Study Type:	Treatment
Study Sponsor:	Sutro Biopharma, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05870748

Summary

A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus
IC chemotherapy in women with ovarian cancer (including fallopian tube or primary
peritoneal cancers) expressing FOLR1.

Objectives

This is a randomized, multicenter, international, open-label, 2-part, Phase 2/3 study
designed to assess the efficacy and safety of luveltamab tazevibulin versus IC
chemotherapy in subjects with relapsed platinum-resistant epithelial ovarian cancer
expressing FOLR1.

Part 1 will consist of 2 luveltamab tazevibulin dosing cohorts (Cohort A and Cohort B),
with subjects randomized 1:1. Part 1 will be used to select the optimized dosing regimen.

Part 2 will further evaluate the efficacy and safety of the selected dosing regimen
versus IC chemotherapy.

Luveltamab tazevibulin will be administered intravenously (IV) over a 1-hour infusion
time every 3 weeks.

Treatment Sites in Georgia

Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler
225 Candler Drive
Savannah, GA 31405
912-819-5778
www.sjchs.org

Doctors:

Sarah Elizabeth Gill MD

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