STRO-002-GM3

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  1008266

• Contact name

  Alex Butte

• Contact email

  abutte@sutrobio.com

• Sponsor organisation

  Sutro Biopharma Inc.

• Eudract number

  2022-003843-82

• Clinicaltrials.gov Identifier

  05870748

• Research summary

  The primary rationale for the study is to investigate the efficacy and safety of luveltamab tazevibulin compared to IC chemotherapy in subjects with relapsed platinum-resistant epithelial ovarian cancer expressing FOLR1. Luveltamab tazevibulin is an antibody-drug conjugate (ADC) targeting FOLR1 which is expressed in approximately 80% of recurrent ovarian cancers, and expression is maintained in metastatic foci and in recurrent carcinomas in patients and following chemotherapy treatment regimens.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  24/EE/0264

• Date of REC Opinion

  14 Feb 2025

• REC opinion

  Further Information Favourable Opinion