A Phase Ib/II Clinical Study of LBL-024 Combination Therapy in Patients With Metastatic Colorectal Carcinoma
brief summary
This study is an open-label, multi-center Phase Ib/II clinical trial evaluating the safety and efficacy of LBL-024 in combination with other drugs for the treatment of metastatic colorectal carcinoma (mCRC), aiming to evaluate the safety and efficacy of LBL-024 in combination with other drugs in the treatment of mCRC patients.
detailed description
This study included phase Ib (safety introduction period) and phase II (randomized controlled extension period).
Phase Ib and Phase II each contain two independent cohorts, Cohort 1 and Cohort 2.
After comprehensive evaluation by the sponsor and investigator, the safety and tolerability of combination therapy in Phase Ib Cohort 1 and Cohort 2 were good, and preliminary efficacy was observed,Participants will be enrolled to conduct the two cohorts of phase II study.The Phase II study design will be adjusted based on results from the Phase Ib study.The population enrolled in Cohort 1 of Phase II will be determined by the results of Cohort 1A and Cohort 1B of Phase Ib.In Cohort 2 of Phase II, eligible participants were randomly assigned to the B1 group and B2 group in a 2: 1 ratio.
official title
An Open-label, Multicenter Phase Ib/II Study to Evaluate the Safety and Efficacy of LBL-024 Combination Therapy in Patients With Metastatic Colorectal Carcinoma