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Monoclonal Antibodies
MCLA-129 for Non-Small Cell Lung Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Merus N.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients with NSCLC, GC/GEJ, HNSCC, or ESCC who have failed prior standard first-line treatment. Patients must have progressed on or be intolerant to therapies that are known to provide clinical benefit. There is no limit to the number of prior treatment regimens
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks until study ends, approximately 2 years
Awards & highlights
Study Summary
This trial will test a new cancer drug to see if it is safe and effective.
Who is the study for?
This trial is for adults with advanced or metastatic solid tumors like NSCLC, HNSCC, GC/GEJ, ESCC who've had no luck with standard treatments. They should be relatively healthy (ECOG 0-1), have a life expectancy of at least 12 weeks, and good organ function. People can't join if they've recently used other investigational drugs or therapies, had major surgery or certain cardiovascular issues.Check my eligibility
What is being tested?
The study tests MCLA-129 alone in patients with various advanced cancers to find the maximum tolerated dose and/or recommended phase two dose. It's an early-phase trial that starts by giving small doses to a few people and increasing it for new groups until doctors find the best dose.See study design
What are the potential side effects?
Possible side effects include typical reactions to cancer therapy such as fatigue, nausea, skin reactions at injection sites, allergic responses to proteins in the drug (like rashes), liver enzyme changes indicating stress on the liver, and potential impact on blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My cancer has not responded to initial treatments.
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My cancer is advanced, cannot be surgically removed, and is considered incurable.
Select...
My kidney function, measured by creatinine levels or clearance, is within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 8 weeks until study ends, approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks until study ends, approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single agent MCLA-129 in patients with NSCLC, GC/GEJ adenocarcinoma, HNSCC or ESCC, with disease progression after prior therapy for advanced/metastatic disease.
To evaluate the ORR of MCLA-129 alone or in combination with Osimertinib in molecularly defined populations of advanced/metastatic solid tumors.
Secondary outcome measures
Area under the concentration versus time curve [AUC0-∞]
Area under the concentration versus time curve from time zero to time t [AUC0-t]
Half-life [t1/2]
+18 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Part 2 Select solid tumors harboring an EGFR or cMet driving mutationExperimental Treatment1 Intervention
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D).
Group II: Part 2 NSCLC harboring cMet exon 14 skipping mutationExperimental Treatment1 Intervention
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D).
Group III: Part 2 NSCLC harboring EGFR exon 20 InsertionExperimental Treatment1 Intervention
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D).
Group IV: Part 2 NSCLC Second-line or moreExperimental Treatment2 Interventions
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg.
Group V: Part 2 NSCLC First-lineExperimental Treatment2 Interventions
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1010
Find a Location
Who is running the clinical trial?
Merus N.V.Lead Sponsor
7 Previous Clinical Trials
985 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have a known history of HIV.I have a history of serious heart problems.I have myocarditis.I have NSCLC, HNSCC, or another solid tumor with specific mutations.My organs are functioning well.My liver function tests are within the required limits.I have a serious fluid buildup around my heart.I haven't had major surgery or radiotherapy in the last 3 weeks.I can provide a sample of my tumor, either one that's already been taken or a new one.I do not have any serious illness like uncontrolled infections or significant lung, metabolic, or mental health issues.I have an active Hepatitis B infection and am not on antiviral treatment.I don't have untreated or symptomatic brain metastases needing immediate treatment.I have lasting side effects from cancer treatment, but my nerve pain and thyroid issues are under control.I do not have heart issues like long QT syndrome or a family history of it.I do not have a serious heart rhythm problem or a very long QT interval.My cancer has not responded to initial treatments.My cancer has spread to the lining of my brain and spinal cord.I had cancer before, but it doesn't affect my current treatment.I haven't had cancer treatment or immunotherapy in the last 4 weeks or less.I have had a blood clot, heart attack, stroke, or similar serious event recently.My cancer is advanced, cannot be surgically removed, and is considered incurable.My kidney function, measured by creatinine levels or clearance, is within the required range.I have severe heart failure or was hospitalized for it within the last 6 months.You have had a severe allergic reaction or experienced harmful side effects from human proteins or any of the other ingredients in the treatment, leading to the permanent discontinuation of those medications.I have had lung conditions needing long-term steroids or immune suppressants in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2 NSCLC harboring EGFR exon 20 Insertion
- Group 2: Part 2 NSCLC harboring cMet exon 14 skipping mutation
- Group 3: Part 2 Select solid tumors harboring an EGFR or cMet driving mutation
- Group 4: Part 2 NSCLC First-line
- Group 5: Part 2 NSCLC Second-line or more
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you tell me how many volunteers are currently participating in this clinical trial?
"Yes, this is an active trial that is looking for 150 individuals at 2 locations. The listing was first put on clinicaltrials.gov on 4/28/2021 and was updated recently on 5/21/2021."
Answered by AI
Can new participants still join this trial?
"According to the website clinicaltrials.gov, this study is still looking for enrolment. The trial was first posted on April 28th, 2021 and was last updated less than a month ago on May 21st, 2021."
Answered by AI
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