# 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

Source: https://onco.cc/trials/nct05870748/  
OnCo record `nct05870748` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2/3 trial of Luveltamab tazevibulin, Pegfilgrastim, Gemcitabine, Paclitaxel / nab-paclitaxel, Pegylated liposomal doxorubicin and Topotecan in Ovarian cancer and Platinum-resistant ovarian cancer, run by Sutro Biopharma, Inc., recorded as terminated on the registry.

## Summary

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 is a phase 2/3 interventional study registered as NCT05870748 by Sutro Biopharma, Inc., with 600 participants recorded, started 2023-07-12 and due to reach its primary completion in 2025-08-26. Interventions recorded: Luveltamab tazevibulin, Pegfilgrastim, Gemcitabine, Paclitaxel, Pegylated liposomal doxorubicin, Topotecan. Conditions recorded: Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Platinum-resistant Ovarian Cancer.

Linked to the drug Luveltamab tazevibulin because the registry names it among its interventions and Ovarian cancer and Platinum-resistant ovarian cancer among its conditions. Registry record only: no result has been read by an editor.

## Fields

- Kind: Trial
- Last checked: 2026-09-22
- Tags: pipeline; ctgov-ingest
- Registry id: NCT05870748
- Phase: 2/3
- Setting: REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) Versus Investigator's Choice (IC) Chemotherapy in Women With Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)
- Sponsor: Sutro Biopharma, Inc.
- Enrolled: 600

## Sources

- ClinicalTrials.gov NCT05870748: https://clinicaltrials.gov/study/NCT05870748

## Connected records

- cancers: [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Platinum-resistant ovarian cancer](https://onco.cc/cancers/platinum-resistant-ovarian-cancer/)
- drugs: [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Luveltamab tazevibulin](https://onco.cc/drugs/luveltamab-tazevibulin/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Pegfilgrastim](https://onco.cc/drugs/pegfilgrastim/), [Pegylated liposomal doxorubicin](https://onco.cc/drugs/pegylated-liposomal-doxorubicin/), [Topotecan](https://onco.cc/drugs/topotecan/)
- companies: [Sutro Biopharma](https://onco.cc/companies/sutro-biopharma/)

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