The Efficacy and Safety of CKD516 Combined With Durvalumab in Patient Refractory Solid Tumors

Dose Escalation cohort (Stage 1) With traditional 3+3 dose-escalation design, the safety, tolerability, and pharmacokinetics of CKD-516 in combination with durvalumab will be evaluated. Three dose levels of CKD-516 (9, 11, 13 mg/m2) will be investigated in combination with durvalumab 1,500 mg. At each dose level, 3 to 6 patients will be enrolled. After completion of 1 cycle of treatment of all patients in each dose level, decision for enrollment of subjects for next dose level will be decided after review of safety profile by safety review (SRM). Extension cohort (Stage 2) Stage 2 is an exploratory study for the evaluation of the efficacy of recommended phase 2 dose (RP2D) of CKD-516 in the combination with Durvalumab in patients with specific types of solid tumors (listed below). Arm 1: Colorectal cancer (CRC) Arm 2: Other cancer (Pancreatic cancer, Cholangiocarcinoma, Stomach cancer, Esophageal cancer)