A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer

Korábbi kezelés

• Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload.
  • Part A:

Más betegség

• Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing chemotherapy.
  • Part B and C:

Egyéb

• Parts A, B and C:
• Have clinically significant proteinuria
  • Part C:
• Have a known pathogenic BRCA1/2 gene alteration (somatic or germline).

• Part A, B, and C:
• Have histologically confirmed high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
• Have confirmed availability of tumor tissue block or slides
• Have radiographic progression on or after most recent line of systemic anticancer therapy
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Have measurable disease per RECIST v1.1
  • Part A:
• Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy.
• Have previously received 1 to 3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior cytotoxic therapy is 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 and C:
• Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (>)6 months of their last administration of platinum therapy
• Have previously received 1 to 2 prior lines of systemic cytotoxic chemotherapy
  • Part B:
• Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.
  • Part C:
• Have not previously received a PARPi treatment.