Clinical Trial

Adv solid tumors incl
ovarian, endometrial, cervix

Phase 1/2 Study of Rina-S in Patients with Locally Advanced and/or Metastatic Solid Tumors

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

Key Eligibility Criteria:

• Histologically or cytologically confirmed metastatic or unresectable solid tumor (detailed below)
• All cohorts require measurable disease per RECIST v1.1
  Part 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 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 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