Clinical Trial

Phase 1/2 Study of Rina-S in Patients with Locally Advanced and/or Metastatic Solid Tumors GCT1184-01 (PRO1184-001)

MOA: Rinatabart sesutecan (Rina-S) is an FRα-directed antibody drug conjugate with an exatecan payload.

Key Eligibility Criteria:

• Cohort B3 – EGFR-mutated NSCLC
  • Must have received EGFR-targeted therapy and plt-based chemo
• Part C – High-grade serous PROC
  • 1-3 prior lines of therapy (1-4 if MIRV was last line)
  • Must have received prior bevacizumab
  • Must have received PARPi if BRCA mutant and PR/CR on plt-based chemo
• Part D – High-grade serous, endometrioid, clear cell OC/PP/FPC
  Cohort D1 – PSOC
  • 1-3 prior lines of therapy
    Cohort D2 – PSOC, PROC, Plt-refractory
  • Plt-refractory must have received ≤2 prior lines of therapy
  • Prior therapy may include bev, PARPi, and MIRV
  • 1-3 prior lines of therapy for PROC
  • 1-4 prior lines of therapy for PSOC