NCT07448116

Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors.

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.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Advanced Tumor

Interventions

Type	Name	Description
DRUG	MCLA-129	MCLA-129 is a bispecific antibody that targets both EGFR and c-Met, simultaneously blocking the signaling pathways of both EGFR and c-Met, thereby inhibiting tumor growth and survival.
DRUG	Ensartinib	Ensartinib acted as a c-MET inhibitor in this study.

Timeline

• Start date: 2026-01-31
• Primary completion: 2029-02-01
• Completion: 2029-08-01
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

1 site across 1 country: China