CI

At a glance

ClinicalIndex Comparison Record
Phase 1Not Yet Recruiting· 172 target
Drug / intervention
MCLA-129: 1500mg or 2000mg IV Q2W +1 moredrug
Likely dose
MCLA-129: 1500mg or 2000mg IV Q2Wfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06015568
NCT06015568Phase 1Not Yet Recruiting

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

Betta Pharmaceuticals Co., Ltd.·interventional·Posted Aug 29, 2023·Updated Aug 29, 2023

In Brief

A Phase 1 clinical trial evaluating MCLA-129: 1500mg or 2000mg IV Q2W and Befotertinib: 75 mg or 100 mg Po QD for Non-Small Cell Lung Cancer、EGFR Sensitive Mutation. Not yet recruiting, targeting 172 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 1Not Yet Recruiting
202420252026202720282029
First PostedAug 29, 2023
Enrollment StartSep 1, 2023
Primary CompletionNov 4, 2028
Study CompletionJul 4, 2029
TodayJul 1, 2026
Enrollment to primary: 5.2 yearsPosted 2.8 years agoPrimary completion in 2.3 years

Interventions

MCLA-129: 1500mg or 2000mg IV Q2Wdrug

Every 28 days is a cycle until disease progression, death, initiation of new anti-tumor treatment, loss of follow-up, or voluntary withdrawal occurs

Befotertinib: 75 mg or 100 mg Po QDdrug

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.