NCT06015568

Study of MCLA-129 Combined With Befotertinib in the Treatment of Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation

Phase I Study of Anti-EGFR/c-Met Bispecific Antibody MCLA-129 Combined With Befotertinib in Patients of Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation To Evaluate The Safety, Pharmacokinetic Characteristics and Antitumor Activity

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerance of MCLA-129 combined with Befotertinib in patients with advanced non-small cell lung cancer with EGFR-sensitive mutations.

Detailed description

This is a phase I study to evaluate the safety, pharmacokinetic characteristics and antitumor activity of anti-EGFR/c-Met bispecific antibody MCLA-129(1500mg Q2W IV or 2000mg Q2W IV) combined with Befotertinib (75 mg once daily for first cycle, then increased to 100 mg once daily, orally) in Patients of advanced non-small cell lung cancer with exon 19 deletion or exon 21 L858R mutation(either alone or in combination with other EGFR mutations).

Conditions

• Non-Small Cell Lung Cancer、EGFR Sensitive Mutation

Interventions

Type	Name	Description
DRUG	MCLA-129: 1500mg or 2000mg IV Q2W	Every 28 days is a cycle until disease progression, death, initiation of new anti-tumor treatment, loss of follow-up, or voluntary withdrawal occurs
DRUG	Befotertinib: 75 mg or 100 mg Po QD	The initial dose of Befotertinib is 75 mg orally once daily (QD) for one cycle, and then increased to 100 mg orally QD in the absence of CTCAE grade ≥ 2 headache or thrombocytopenia during the first cycle, otherwise maintained to 75 mg orally QD. Every 28 days is a cycle until disease progression, death, initiation of new anti-tumor treatment, loss of follow-up, or voluntary withdrawal occurs.

Timeline

• Start date: 2023-09-01
• Primary completion: 2028-11-04
• Completion: 2029-07-04
• First posted: 2023-08-29
• Last updated: 2023-08-29

Locations

3 sites across 1 country: China