NCT06885840

Study of MCLA-129 in the Treatment of Advanced Non-small Cell Lung Cancer with AGA and MET Amplification.

A Multi-cohort, Open-label Phase II Study to Evaluate the Efficacy and Safety of the Anti-EGFR/c-Met Bispecific Antibody MCLA-129 in Patients with Advanced Non-Small Cell Lung Cancer with Actionable Gene Alterations and MET Amplification.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label, phase II clinical study of MCLA-129 as monotherapy in patients with advanced non-small cell lung cancer (NSCLC) with actionable gene alterations and MET amplification to evaluate the efficacy, safety, pharmacokinetic characteristics of MCLA-129.

Detailed description

This is a multi-center, open-label, monotherapy, multi-cohort phase II study of MCLA-129 in patients with advanced non-small cell lung cancer (NSCLC) with actionable gene alterations and MET amplification, designed to evaluate the efficacy, safety, and PK profiles of MCLA-129 in the target population. Subjects who must experience disease progression or intolerance after standard treatment eligible through screening will be divided into the following 4 cohorts: Cohort 1 and Cohort 2: Patients with advanced NSCLC with previously detected EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation) who have progressed after prior standard treatment which includes 1) first-generation or second-generation EGFR-TKIs, with T790M mutation requiring third-generation EGFR-TKIs and platinum-based chemotherapy; or 2) first-generation or second-generation EGFR-TKIs, with T790M mutation negative or unknown status. Subjects in Cohort 1: Patients with MET amplification after failure of treatment with EGFR-TKIs. Subjects in Cohort 2: Patients who experienced disease progression or intolerance after MET inhibitors and benefited from such treatment. Cohort 3 and Cohort 4: Patients with advanced NSCLC with previously detected actionable gene alterations who had progressed after treatment with corresponding inhibitors and platinum-based chemotherapy. Subjects in Cohort 3: Patients with MET amplification, after failure of treatment with the corresponding driver gene inhibitors. Subjects in Cohort 4 should also meet: Patients who experienced disease progression or intolerance after MET inhibitors and benefited from such treatment.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	MCLA-129	MCLA-129 will be administered by intravenous infusion on the 28-day treatment cycle.

Timeline

• Start date: 2025-03-31
• Primary completion: 2028-04-01
• Completion: 2028-09-01
• First posted: 2025-03-20
• Last updated: 2025-03-20

Locations

20 sites across 1 country: China