drugset / Trial / NCT05870748
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
Phase 2/3
Terminated
600 enrolled
Sutro Biopharma, Inc.
Asia-Pacific Gynecologic Oncology Trials Group · collabEuropean Network of Gynaecological Oncological Trial Groups (ENGOT) · collabGOG Foundation · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-07-12
- Primary completion
- 2025-08-26
- Completion
- 2025-08-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Doxorubicin | Other / unclassified | 40 mg/m2 | — |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Luveltamab tazevibulin | Monoclonal antibody | 4.3 mg/kg | Intravenous |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Comparator | Topotecan | Small molecule | 1.25 mg/m2 | — |
| Comparator | Topotecan | Small molecule | 4 mg/m2 | — |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | — |