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Comparing Luveltamab Tazevibulin to Standard Chemotherapy for Ovarian Cancer

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)

Phase2; Phase3 Interventional Sutro Biopharma, Inc. · NCT05870748

This study is testing a new treatment called luveltamab tazevibulin to see if it works better and is safer than standard chemotherapy for women with relapsed ovarian cancer that doesn't respond to platinum-based treatments.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment600 (estimated)
Ages18 Years and up
SexFemale
SponsorSutro Biopharma, Inc. Industry-sponsored
Drugs / interventionsbevacizumab, luveltamab, chemotherapy
Locations39 sites (Tucson, Arizona and 38 other locations)
Trial IDNCT05870748 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of luveltamab tazevibulin compared to investigator's choice chemotherapy in women with relapsed platinum-resistant ovarian cancer that expresses FOLR1. It is a randomized, multicenter, international trial divided into two parts: the first part aims to determine the optimal dosing regimen of luveltamab tazevibulin, while the second part evaluates its efficacy and safety against standard chemotherapy. Participants will receive the treatment intravenously every three weeks.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with high-grade serous epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer that expresses FOLR1.

Not a fit: Patients with low-grade ovarian carcinoma or those who have previously received FOLR1-targeting therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for women with difficult-to-treat ovarian cancer.

How similar studies have performed: Other studies have shown promise with similar approaches targeting FOLR1, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. High grade serous epithelial ovarian cancer, fallopian tube or primary peritoneal cancer
2. Age ≥ 18 years
3. ECOG performance status 0 to 1
4. Positive FOLR1 expression per central laboratory testing
5. Relapsed platinum-resistant epithelial ovarian cancer and received a total of 1 to 3 prior regimens
6. Prior bevacizumab treatment is required, if labeled and available as standard of care per institutional guidelines, unless subject has documented contraindication
7. At least 1 measurable target lesion per RECIST v1.1
8. Adequate organ function

Exclusion Criteria:

1. Low grade (Grade 1) ovarian carcinoma, clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas
2. Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor
3. Primary platinum-refractory disease
4. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
5. Pre-existing clinically significant ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
6. Previous solid organ transplantation
7. History or clinical signs of meningeal or active central nervous system involvement
8. Concurrent participation in another therapeutic treatment trial

Where this trial is running

Tucson, Arizona and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ovarian CancerEpithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal CancerPlatinum-resistant Ovarian CancerFOLR1FolRαFRα
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.