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

Colorectal Cancer Clinical Trial

Official title: A Phase I Study to Determine the Efficacy and Safety of CKD-516 Tablet Combined With Durvalumab(MEDI4736) in Patient Refractory Solid Tumors

Status Terminated

Clinical Trial Summary

This is a single center, open-label, nonrandomized, Phase 1b, dose-escalation study designed to determine maximum tolerated dose (MTD) of CKD-516 in combination with durvalumab and evaluate the safety and tolerability profile, efficacy of CKD-516 and durvalumab treatment.

Clinical Trial Description

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) ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasms
• Solid Tumor

• NCT number: NCT04696848
• Study type: Interventional
• Source: Asan Medical Center
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 24, 2021
• Completion date: March 9, 2023