DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors
Trial Parameters
Brief Summary
This is a multicenter, open-label, Phase 1 study to assess the effects of DCSZ11 as a monotherapy and in combination in patients with advanced or metastatic solid tumors. The study consists of an Escalation Phase (Phase 1a) and a Dose Expansion/Optimization Phase (Phase 1b).
Eligibility Criteria
Selected Inclusion Criteria: 1. Male or female patients ≥ 18 years of age. 2. Be willing and able to provide written informed consent for the study. 3. Patients in Phase 1a must have a histologically or cytologically documented, advanced (metastatic and/or unresectable) solid tumor that has progressed on or after standard therapy (relapsed/refractory patients; patients must have failed at least one prior line of therapy) or for whom there is no effective standard therapy based on the Investigator's judgment. Note: Patients with glioblastoma (GBM) or other central nervous system(CNS) tumors may participate if they are on stable or decreasing corticosteroid levels not exceeding 2 mg/day dexamethasone (or equivalent doses of other corticosteroids) within 7 days of the first dose of study drug or do not require corticosteroids. Note: For patients who are intolerant to or refuse standard-of-care therapy for recurrent disease, reasons must be documented. 4. Patients in Phase 1b Dose Optimiza