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Monoclonal Antibodies
MCLA-158 for Solid Cancers
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
Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 months
Awards & highlights
Study Summary
This trial is testing a drug to see how safe, effective and tolerable it is for treating certain tumors.
Who is the study for?
This trial is for adults with advanced solid tumors like lung, stomach, colorectal cancers that can't be cured by standard treatments. They must have a fresh tumor sample available and measurable disease. Good physical condition (ECOG 0 or 1) and proper organ function are required. Exclusions include recent major surgery, heart issues, other malignancies within 3 years, active infections, or uncontrolled medical conditions.Check my eligibility
What is being tested?
The study tests MCLA-158 in patients with metastatic colorectal cancer (mCRC) and other solid tumors dependent on EGFR inhibition. It's an open-label trial to determine the safest dose of MCLA-158 that also works best (RP2D). The study will evaluate safety, how the body processes the drug (PK/PD), immune response to it (immunogenicity), and its effectiveness against tumors.See study design
What are the potential side effects?
While specific side effects for MCLA-158 aren't listed here as it's early in testing, similar drugs often cause reactions at injection sites, flu-like symptoms such as fever and chills, fatigue, nausea or diarrhea. There may also be risks of allergic reactions or effects on liver function which will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread and cannot be cured with standard treatments.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I can provide a recent tumor sample from the primary or metastatic site.
Select...
My cancer in the head, neck, stomach, or gastroesophageal junction is EGFR positive.
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I can undergo a biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Expansion (Combination): Safety and tolerability: AEs and SAEs
Escalation and Expansion: Safety and tolerability
Escalation and Expansion: Safety and tolerability: (ECG)
+11 moreSecondary outcome measures
Escalation & Expansion (non-randomized cohort): Cytokine Panel Expression Profile
Escalation & Expansion: Area under the concentration versus time curve [AUC0-∞]
Escalation & Expansion: Area under the concentration versus time curve from time zero to time t [AUC0-t]
+22 moreOther outcome measures
Escalation & Expansion: Biomarkers for Wnt signaling proteins
Escalation & Expansion: Biomarkers for differential expression of mRNA
Escalation & Expansion: Biomarkers for differential expression of miRNA
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: MCLA-158 + PembrolizumabExperimental Treatment1 Intervention
MCLA-158 in combination with pembrolizumab will be explored first in head and neck squamous cell carcinoma patients eligible to receive pembrolizumab as first-line monotherapy.
Group II: MCLA-158Experimental Treatment1 Intervention
In Part 1, the dose escalation phase, patients with metastatic CRC will receive escalating doses of MCLA-158 (every 2 weeks) until MTD or RP2D is reached. Each Cycle is 28 days. Single agent treatment. In Part 2, the expansion phase, participants with metastatic CRC and certain other solid tumors will receive intravenous infusion of MCLA-158 at the recommended Phase II dose (RP2D) every 2 weeks, at Day 1 and Day 15. The duration of each treatment cycle is 28 days.
In the expansion phase, 2 doses (1100 mg and 1500 mg) of MCLA-158 will be evaluated in a cohort of head and neck squamous cell carcinoma patients
Find a Location
Who is running the clinical trial?
Merus N.V.Lead Sponsor
7 Previous Clinical Trials
1,005 Total Patients Enrolled
Chiltern International Inc.Industry Sponsor
15 Previous Clinical Trials
7,353 Total Patients Enrolled
Q2 SolutionsIndustry Sponsor
13 Previous Clinical Trials
798 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread and cannot be cured with standard treatments.I have squamous cell carcinoma of the lung.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had cancer treatment in the last 4 weeks or longer.I haven't had major surgery or radiotherapy in the last 3 weeks.I have serious heart issues, but not atrial fibrillation or sudden fast heartbeats.I have no cancer history except for treated skin cancer or low-risk cancers clear for 3+ years.I am currently taking medication to suppress my immune system.I have active hepatitis B and am not on antiviral treatment.I can provide a recent tumor sample from the primary or metastatic site.I have a history of lung disease or signs of it on a chest scan.My liver disease is severe, and my cancer type is specific and aggressive.My cancer in the head, neck, stomach, or gastroesophageal junction is EGFR positive.I have had a heart attack in the last 6 months.My brain metastases are either untreated, causing symptoms, or need treatment to manage symptoms.I do not have any serious illness like uncontrolled infections or significant lung, metabolic, or mental health issues.My cancer has spread to the lining of my brain and spinal cord.I have lasting side effects from cancer treatment, but no severe nerve pain.I can undergo a biopsy.My blood pressure is high (>150/100 mmHg) despite treatment, or I have unstable chest pain.My organs are working well.I need oxygen therapy all the time due to difficulty breathing.I am not pregnant or breastfeeding and will use effective birth control during and 6 months after the study.
Research Study Groups:
This trial has the following groups:- Group 1: MCLA-158
- Group 2: MCLA-158 + Pembrolizumab
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.
What is the current enrollment count for this research trial?
"Affirmative. The information posted to clinicaltrials.gov verifies that this medical research is seeking participants, with 360 patients expected to be recruited from 14 locations since its initial posting in May 2018 and most recent update on February 15th 2023."
Answered by AI
How many healthcare centers offer this clinical trial?
"This clinical trial has multiple enrolling sites, including the Hopital Saint Andre and CHU Bordeaux in Bordeaux, Centre Leon Berard in Lyon, and Hopital La Timone in Marseille. Additionally, 10 other medical centres are also offering this treatment."
Answered by AI
Are participants being accepted for enrollment in this clinical trial at present?
"Correct. According to information available on clinicaltrials.gov, this medical research project is currently recruiting participants; it was originally posted on May 2nd 2018 and last modified on February 15th 2023. A total of 360 individuals need to be signed up from 14 diverse centres."
Answered by AI
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