Georgia's Online Cancer Information Center

Find A Clinical Trial

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

Status
Active
Cancer Type
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Unknown Primary
Trial Phase
Phase II
Phase III
Eligibility
18 Years and older, Female
Study Type
Treatment
NCT ID
NCT05870748
Protocol IDs
STRO-002-GM3 (primary)
NCI-2023-04597
APGOT-OV9
ENGOT-OV79
GEICO-134-O
GOG-3086
Study Sponsor
Sutro Biopharma, Inc.

Summary

A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus
IC chemotherapy in women with ovarian cancer (including fallopian tube or primary
peritoneal cancers) expressing FOLR1.

Objectives

This is a randomized, multicenter, international, open-label, 2-part, Phase 2/3 study
designed to assess the efficacy and safety of luveltamab tazevibulin versus IC
chemotherapy in subjects with relapsed platinum-resistant epithelial ovarian cancer
expressing FOLR1.

Part 1 will consist of 2 luveltamab tazevibulin dosing cohorts (Cohort A and Cohort B),
with subjects randomized 1:1. Part 1 will be used to select the optimized dosing regimen.

Part 2 will further evaluate the efficacy and safety of the selected dosing regimen
versus IC chemotherapy.

Luveltamab tazevibulin will be administered intravenously (IV) over a 1-hour infusion
time every 3 weeks.

Eligibility

  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

Treatment Sites in Georgia

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.