NCT05870748Phase 2, phase 3Terminated

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

Study sponsor: Sutro Biopharma, Inc. · STRO

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-08-26Actual

Enrollment · participants600Actual

Source updated2025-09-23Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Ovarian Cancer; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer; Platinum-resistant Ovarian Cancer

Treatments or interventions studied

Luveltamab tazevibulinDrugAlso known as STRO-002, Luvelta
PegfilgrastimDrugAlso known as Neulasta
GemcitabineDrug
PaclitaxelDrug
Pegylated liposomal doxorubicinDrug
TopotecanDrug

Primary outcomes · main study measures

measure: Progression Free Survival (PFS); description: time between the date of first dose and the first date of documented progression or death; timeFrame: up to 24 months; measure: Objective Response Rate (ORR); description: Best response of complete response (CR) or partial response (PR) per RECIST 1.1.; timeFrame: up to 24 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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