Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors.
brief summary
This is a multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of the anti-EGFR/c-Met bispecific antibody MCLA-129 in combination with Ensartinib hydrochloride in patients with advanced solid tumors.
detailed description
This is a multi-center, open-label Phase I/II clinical study of MCLA-129 in combination with ensartinib in patients with advanced solid tumors to evaluate the efficacy, safety, and pharmacokinetics of MCLA-129 in combination with ensartinib. The study is divided into two parts: Phase I is a dose-exploration study to confirm the safe tolerability and recommended Phase II combination dose (RP2CD) of MCLA-129 in combination with ensartinib, and Phase II is a parallel cohort expansion study to further evaluate the efficacy, safety, and pharmacokinetics (PK) of MCLA-129 in combination with ensartinib in patients with advanced solid tumors in cohorts.
Primary Objectives of Phase I:
To evaluate the safety and tolerability of MCLA-129 in combination with ensartinib in patients with advanced solid tumors, and to determine potential dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD) To determine the recommended Phase II combination dose (RP2CD) of MCLA-129 in combination with ensartinib.
Secondary Objectives of Phase I:
To evaluate the pharmacokinetic (PK) profile of MCLA-129 in combination with ensartinib in patients with advanced solid tumors To preliminarily evaluate the efficacy of MCLA-129 in combination with ensartinib in patients with advanced solid tumors To evaluate the immunogenicity of MCLA-129
Primary Objectives of Phase II:
To evaluate the efficacy of MCLA-129 in combination with ensartinib at the RP2CD in patients with advanced solid tumors across different cohorts.
Secondary Objectives of Phase II:
To evaluate the safety of MCLA-129 in combination with ensartinib at the RP2CD in patients with advanced solid tumors.
To evaluate the immunogenicity of MCLA-129.
official title
A Multi-cohort, Open-label Phase I/II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of the Anti-EGFR/c-Met Bispecific Antibody MCLA-129 in Combination With Ensartinib Hydrochloride in Patients With Advanced Solid Tumors.