Clinical trial · Interventional
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
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to strategic business considerations, Sutro has deprioritized the development of luveltamab tazevibulin, leading to termination of the REFRaME program. This decision is not related to any safety or efficacy concerns associated with luvelta
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Platinum-resistant Ovarian Cancer | Platinum-Resistant Ovarian Carcinoma | ALIAS | 0.90 |
| Primary Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Luveltamab tazevibulin | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
| Pegylated liposomal doxorubicin | Drug | — | UNRESOLVED |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Luveltamab tazevibulin dose Cohort A
- description
- 5.2 mg/kg q3w with prophylactic pegfilgrastim for 2 cycles followed by 4.3 mg/kg q3w for Cycle 3 onwards
- interventionNames
- Drug: Luveltamab tazevibulin
- Drug: Pegfilgrastim
- type
- EXPERIMENTAL
- label
- Luveltamab tazevibulin dose Cohort B
- description
- 4.3 mg/kg q3w
- interventionNames
- Drug: Luveltamab tazevibulin
- type
- ACTIVE_COMPARATOR
- label
- Part 2: IC Chemotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available