A Phase 1a/1b, Multicenter, Open-label, Dose Escalation/Expansion, Multiple-dose Study to Evaluate the Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas
A phase 1a/1b, multicenter, open-label, dose escalation/expansion, multiple-dose study to evaluate the safety and activity of DR-0202 in patients with locally advanced or metastatic, relapsed or refractory carcinomas
• Histologically confirmed epithelial cancer of the following tumor types: breast (TNBC, HR+/HER2-/+BC), NSCLC, cervical, CRPC, PDAC, HNSCC, endometrial, ovarian, gastric/GEJ, or urothelial that is unresectable, locally advanced or metastatic
• Relapsed or refractory with at least 2 prior lines of therapy and for which no standard of care treatment options are available
• Radiographically measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Life expectancy, in the opinion of the Investigator, of ≥ 3 months
• Adequate marrow reserve, renal function, and hepatic function
• Taper of ≥ 2 weeks from high-dose systemic corticosteroids (however, low dose corticosteroids ≤ 25 mg prednisone or equivalent daily are permitted in consultation with the Medical Monitor)
• Willing to provide archival tumor tissue samples or agree to a baseline biopsy if not available
• Willing to undergo an on-treatment biopsy if clinically feasible and not contraindicated at the time of procedure