Clinical Trial

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

MOA: Rina-S is an FRα-directed antibody-drug conjugate with an exatecan payload (topoisomerase I inhibitor)

Key Eligibility Criteria:

• Cohort B3 – EGFR-mutated NSCLC
  • HistologiPart B5: Endometrial Carcinosarcoma
    Neuroendocrine and pure sarcoma excluded
    1-3 prior lines of therapy,
    Must have received prior plt-based chemo and PD-(L)1 inhibitor
    If PD >12 months after plt, must receive 1 add plt-based chemo unless
    IO is administered in recurrent setting
    Prior ADC with TOP1i payload excluded
• Part C – High-grade serous PROC
  • 1-3Part B6: Cervical
  • Histologically confirmed squamous cell carcinoma, adenosquamous
    carcinoma, adenocarcinoma of cervix
  • Progression on or after tx with plt doublet ± bev AND anti-PD-(L)1 tx
  • Received ≤2 systemic tx for rec/met cervical cancer
  • Prior ADC with TOP1i payload excluded
• Part D – High-grade serous, endometrioid, clear cell OC/PP/FPC
  Cohort D1 – PSOC
  • 1-3Part I: Ovarian
  • High-grade serous, high-grade endometrioid
  • Plt-sensitive, progression >183 days after 1L plt ± bev
  • Must have BRCA1/2 mutated or HRD positive tumor
  • Must have received and PD on 1L PARPi maintenance (± bev)
  • Must have received only 1 prior line of tx
  • Prior MIRV or ADC with TOP1i payload excluded
• Part J: Ovarian
• High-grade, including serous, endometrioid, clear cell histologies
• 1-3 prior lines of therapy
• Plt-resistant disease, primary plt-refractory excluded
• Pts w/ known or suspected BRCA mutation must have received PARPi
• Known positive FRα (≥75% by Ventana FOLR1 RxDx, local testing)
• Prior tx w/ FRα-targeted ADC (incl MIRV) or ADC with TOP1i payload
  excluded