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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

Study Status Open To Accrual
National Clinical Trial Identifier NCT05870748
Phase II
  • Full Title

    A Phase II Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) in Women with Relapsed Platinum-resistant Epithelial Ovarian Cancer (including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor alpha (FOLR1)

  • Purpose
    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.
  • Objective
    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
    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
  • Resources & Links
  • Interested in this Trial?
    If you are interested in participating in this study, call The JamesLine at 800-293-5066 to make an appointment with the principal investigator listed or ask your doctor if you are eligible for this study.

Trial Information

Protocol Number:OSU-23243
Gender:Female
Disease Group:Gynecologic