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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
FRα Antibody-Drug Conjugate
Sofetabart mipitecan
Phase
3
Recruiting
Recruiting Info
FRAmework-01: A Three-Part Phase 3 Study of Sofe-M Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofe-M Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer
Related Resources:
FRAmework-01 Trial
Key Inclusion Criteria
  • Parts A, B, and C:
    • Have histologically confirmed high-grade serous ovarian or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancer
    • Have confirmed availability of tumor tissue block or slides
    • Have radiographic progression on or after the most recent line of systemic anticancer therapy
    • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
    • Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Part A:
    • Have platinum-resistant disease, defined as radiographic progression ≤6 months after the last dose of platinum therapy
    • Have previously received ≥1 but ≤3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior therapy are allowed if one of those lines is mirvetuximab soravtansine
    • Have received prior bevacizumab treatment, unless documented contraindication or intolerance
    • Have received treatment with a poly(ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or
      germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or
      intolerance
  • Part B:
    • Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression >6 months after their last dose of platinum therapy
    • Have previously received ≥1 but ≤2 prior lines of systemic cytotoxic chemotherapy
    • Have previously received a PARPi, per local product label, with progression on or within 6 months of completion of PARPi treatment
  • Part C:
    • Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease, defined as radiographic progression >6 months after their last dose of platinum therapy
    • Have previously received ≥1 but ≤2 prior lines of systemic cytotoxic chemotherapy
Key Exclusion Criteria
  • Parts A, B, and C:
    • Have received prior antibody-drug conjugate (ADC) with a topoisomerase payload
  • Part A:
    • Have primary platinum-refractory disease, defined as a disease that has progressed for ≤3 months since the last dose of first-line platinum-containing chemotherapy
  • Part B:
    • Have clinically significant proteinuria
  • Part C:
    • Have known BRCA 1/2 gene alterations (somatic or germline)
    • Have received treatment with a PARPi
    • Have clinically significant proteinuria
a
3 mg/kg, administered intravenously every 3 weeks (Q3W).
b
Paclitaxel, PLD, gemcitabine or topotecan.
c
Mirvetuximab if eligible, where available.
d
Carboplatin+paclitaxel or carboplatin+gemcitabine or carboplatin+PLD.
For information on trial enrollment, locations, and more, call 1-877-285-4559.
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