Actively Recruiting
Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors.
Led by Betta Pharmaceuticals Co., Ltd. · Updated on 2026-03-04
164
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, any gender
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors not curable by other therapies
- Confirmed MET amplification or overexpression by specified laboratory tests
- For Phase I: Disease progression or intolerance to standard treatments or unsuitable for platinum-based chemotherapy
- For Phase II: Specific cohort criteria for non-small cell lung cancer, squamous cell carcinoma of head and neck, or gastric/gastroesophageal junction adenocarcinoma with prior treatment requirements
- Must have evaluable or measurable lesions according to RECIST v1.1
- ECOG performance status of 0-1
- Expected survival of 3 months or more
- Adequate organ function without recent blood transfusion or growth factor support
- Willing and able to follow trial procedures and provide informed consent
You will not qualify if you...
- ALK positive non-small cell lung cancer patients
- Recent use of investigational or antitumor drugs, including certain traditional Chinese medicines
- Major surgery or radiotherapy within 4 weeks prior to first dose (some exceptions apply)
- Excessive prior lines of systemic chemotherapy or anti-tumor treatments
- Prior use of EGFR/c-Met bispecific antibodies or ADC drugs
- Need for strong CYP3A inhibitors or inducers during the study
- Unresolved toxicities from prior treatments above Grade 1 (except alopecia)
- Other malignancies within past 3 years except certain cured or local cancers
- Brain or CNS malignancies or active brain metastases depending on cohort
- Significant cardiovascular or cerebrovascular diseases
- Active hepatitis B, hepatitis C, HIV, or syphilis infection (with some exceptions)
- History or current evidence of interstitial lung disease or pneumonia
- Severe or uncontrolled medical conditions including infections or pulmonary disorders
- Active bleeding or gastrointestinal issues interfering with drug absorption
- Hepatic encephalopathy, hepatorenal syndrome, or moderate to severe liver cirrhosis
- Pregnant or breastfeeding women or those unwilling to use contraception
- Allergy to study drugs or their components
- Poor compliance or inability to follow study procedures as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
M
Ming Ma, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here