CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 400 target
Drug / intervention
MCLA-129drug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Age ≥18 years
  • ✓Metastatic or unresectable advanced NSCLC or other solid tumors (head and neck, colorectal, etc.) with disease progression, standard treatment intolerance, or refusal (except Part 2)
  • ✓EGFR positive and/or MET positive (Part 1)
  • ✓Evaluable lesions (dose escalation) or measurable lesions per RECIST v1.1 (others)
Key exclusion· 17
  • ✕For colorectal cancer: HER-2 positivity (IHC 2+/3+ or FISH/NGS+)
  • ✕Investigational product or anti-tumor drug within 14 days or 5 half-lives (whichever longer); for cohort E, <6 months since EGFR monoclonal antibody
  • ✕Major surgery or radiotherapy (except palliative ≥2 weeks prior) within 4 weeks
  • ✕For colorectal cancer, head/neck SCC, or gastric/GEJ adenocarcinoma: >3 lines of prior systemic anti-tumor therapy (excluding maintenance)

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

Search/NCT04930432
NCT04930432Phase 2RecruitingHigh MomentumUpdated 4mo ago
Long Recruiting
CompareCT.gov

A Phase I/II Study of MCLA-129, a Human Anti-EGFR and Anti-c-Met Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors, Evaluating Safety, Pharmacokinetic Characteristics and Antitumor Activity

Betta Pharmaceuticals Co., Ltd.·interventional·Posted Jun 18, 2021·Updated Feb 10, 2026

In Brief

A Phase 2 clinical trial evaluating MCLA-129 for Solid Tumor and 3 related conditions. Currently recruiting, targeting 400 participants across 87 sites.

Signals

Enrolling ahead of pace

Detailed Summary

This is a multi-center, open-label, Phase I/II clinical study of MCLA-129 as monotherapy in patients with advanced solid tumors to evaluate the safety, pharmacokinetic characteristics and antitumor activity of MCLA-129.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Colorectal Cancer
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
20222023202420252026202720282029
First PostedJun 18, 2021
Enrollment StartSep 24, 2021
Primary CompletionApr 30, 2028
Study CompletionDec 30, 2028
TodayJul 1, 2026
Enrollment to primary: 6.6 yearsPosted 5.0 years agoPrimary completion in 1.8 years

Interventions

MCLA-129drug

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