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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)

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Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 18 Mar 2025

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At a glance

  • Drugs Luveltamab tazevibulin (Primary) ; Pegfilgrastim (Primary)
  • Indications Carcinoma; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms FOLR1; REFRaME-O1
  • Sponsors Sutro Biopharma

    • Most Recent Events

    • 15 Mar 2025 According to Sutro Biopharma media release, expanded data in a late-breaking oral presentation from the dose-optimization portion of the trial at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer. The SGO Annual Meeting will take place from March 14-17, 2025 in Seattle, Washington.
    • 10 Dec 2024 According to Sutro Biopharma media release, the company plans to present additional data at future medical meetings; Luvelta is positioned for an Accelerated Approval application in mid-2027.
    • 10 Dec 2024 Topline results from dose-optimization portion of REFRaME-O1 trial in Platinum Resistant Ovarian Cancer presented in the Sutro Biopharma Media Release

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