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
← catalyst calendarSponsored by Sutro Biopharma, Inc. (industry) · STRO — their whole pipeline →. With European Network of Gynaecological Oncological Trial Groups (ENGOT), Asia-Pacific Gynecologic Oncology Trials Group, GOG Foundation.
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Due to strategic business considerations, Sutro has deprioritized the development of luveltamab tazevibulin, leading to termination of the REFRaME program. This decision is not related to any safety or efficacy concerns associated with luvelta
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-07-12 | actual | When the study began enrolling |
| Primary completion | 2025-08-26 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-08-26 | actual | The whole study's end, after follow-up |
| First posted | 2023-05-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-09-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Ovarian Cancer
- Epithelial Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Cancer
- Platinum-resistant Ovarian Cancer
Interventions
- Drug: Luveltamab tazevibulin — also filed as STRO-002, Luvelta
- Drug: Pegfilgrastim — also filed as Neulasta
- Drug: Gemcitabine
- Drug: Paclitaxel
- Drug: Pegylated liposomal doxorubicin
- Drug: Topotecan
Primary outcomes
what the primary-completion date above is the date OFPermalink · STRO's whole pipeline · Catalyst calendar · Every registered study · What changed