Colorectal Cancer Clinical Trial
Official title:
A Phase 1/2 Open-label, Multi-center Study of the Safety, Pharmacokinetics, and Anti-tumor Activity of LYT-200 as a Single Agent and in Combination With Chemotherapy or Tislelizumab in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 Open-label, Multi-center Study of the Safety, Pharmacokinetics, and Anti-tumor Activity of LYT-200 Alone and in Combination with Chemotherapy or Tislelizumab in Patients with Metastatic Solid Tumors
This is an open-label, uncontrolled, multicenter Phase 1/2 study with a dose escalation phase (Part 1) and a cohort expansion phase (Part 2) in patients with relapsed/refractory metastatic solid tumors. Part 1: Dose Escalation Phase_Single Agent A dose-finding study will be conducted using a continuous reassessment method (CRM) to establish dose-limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D). Part 1: Dose Escalation Phase_Combination A dose-finding combination study with chemotherapy or tislelizumab will be conducted using a 4+2 study design to establish dose-limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D). Part 2: The second part of the protocol will be a dose expansion in both/or either single agent or combination based on the RP2D determined in Part 1, in patients with metastatic/advanced solid tumors. ;
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