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

Launched by SUTRO BIOPHARMA, INC. · May 12, 2023

Keywords

ClinConnect Summary

The REFRaME-O1 clinical trial is studying a new treatment called luveltamab tazevibulin to see how well it works and how safe it is compared to standard chemotherapy for women with certain types of ovarian cancer. This includes cancers that start in the ovaries, fallopian tubes, or the lining of the abdomen, particularly in women whose cancer has come back after treatment and is resistant to platinum-based therapies. The trial is looking for women aged 18 and older who have been diagnosed with high-grade serous epithelial ovarian cancer and have a specific marker (FOLR1) that can be tested in the lab. Participants should have had 1 to 3 previous treatments for their cancer and may have received a drug called bevacizumab, unless they cannot due to health reasons.

Women who join the trial can expect to receive either the new treatment or a choice of standard chemotherapy, depending on what the study assigns. The goal is to see if luveltamab tazevibulin can provide better outcomes for patients. It’s important to note that certain women may not be eligible, especially those with specific types of ovarian cancer or serious health issues. If you or someone you know is interested in participating, it’s a good idea to discuss this with a healthcare provider to see if it’s a suitable option.

Gender

FEMALE

Eligibility 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