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

NCT07448116 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-03-04

No results posted yet for this study

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.

Conditions

  • Solid Advanced Tumor

Interventions

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.

Sponsors & Collaborators

  • Betta Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2029-02-01
Completion
2029-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07448116 on ClinicalTrials.gov