Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and… (NCT04930432) | Clinical Trial Compass
RecruitingPhase 1/2
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
China400 participantsStarted 2021-09-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects are ≥ 18 years of age, regardless of gender.
* Subjects must have histologically or cytologically confirmed metastatic or unresectable advanced NSCLC or other solid tumors (including but not limited to head and neck cancer, colorectal cancer, etc.), have disease progression after standard treatment, or are intolerant to standard treatment, or refuse standard treatment (Refusal of standard treatment does not apply to Part 2).
* For Part 1, subjects must be diagnosed with EGFR positive and/or MET positive by testing.
For patients with advanced NSCLC, EGFR positive is defined as: EGFR mutation or EGFR amplification. MET positive is defined as: MET amplification or MET exon 14 skipping mutation.
For patients with other advanced solid tumors other than NSCLC, EGFR positive is defined as: High EGFR expression or EGFR amplification. MET positive is defined as: c-Met high expression or MET amplification.
• For Part 2, patients shall meet the inclusion criteria for each cohort by biomarker testing.
Cohort A: Patients with advanced NSCLC who are previously diagnosed with EGFR mutations and treated with third-generation EGFR-TKIs for drug resistance.
Cohort B: Advanced NSCLC patients diagnosed with EGFR exon 20 insertion mutation (Exon20ins).
Cohort C: Advanced NSCLC patients with MET amplification. Cohort D: Advanced NSCLC patients with MET exon 14 skipping mutation (Exon14 skipping).
Cohort E: Patients with locally advanced or recurrent metastati…
What they're measuring
1
Dose-Limiting Toxicity (DLT) in Part 1
Timeframe: First 28 days of treatment
2
Maximum Tolerated Dose (MTD) in Part 1
Timeframe: First 28 days of treatment
3
Overall Response Rate (ORR) in Part 2
Timeframe: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
4
Treatment-Emergent Adverse Event (TEAE) in Part 1 and 2