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

• Status: Not yet recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sutro Biopharma, Inc.

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. Must have received prior bevacizumab for treatment of ovarian cancer or have a documented contraindication to receive bevacizumab

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