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Monoclonal Antibodies
Zenocutuzumab for Solid Tumors
Phase 2
Recruiting
Led By Alison Schram, MD
Research Sponsored by Merus N.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Absolute neutrophil count ≥1.5 x 10^9/L without colony stimulating factor support for at least 7 days prior to screening
Performance status of ECOG 0 - 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 months
Awards & highlights
Study Summary
This trial is testing a new drug, zenocutuzumab, to see if it is safe and effective for treating patients with solid tumors that have an NRG1 fusion.
Who is the study for?
This trial is for adults with advanced solid tumors that have a specific genetic change called an NRG1 fusion. They should have tried standard treatments or be unsuitable for them, and must not be pregnant or breastfeeding. Participants need to have a life expectancy of at least 12 weeks, stable organ function, and no serious heart conditions or uncontrolled infections.Check my eligibility
What is being tested?
The study tests Zenocutuzumab (MCLA-128), focusing on its safety, how the body processes it, and its effectiveness against tumors with NRG1 fusions. It's an early-stage trial involving dose adjustments to find the right balance between safety and efficacy.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system since Zenocutuzumab is designed to target cancer cells but may affect normal cells too. Specific side effects are not listed but generally could involve fatigue, nausea, allergic reactions, and impacts on blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My white blood cell count is healthy without needing medication for the past week.
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I am able to care for myself and perform daily activities.
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My platelet count is healthy without needing a transfusion in the last week.
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My cancer is advanced, cannot be surgically removed, and has an NRG1 gene fusion.
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
Duration of response per RECIST v1.1 as per local Investigator's assessment.
Objective overall response rate (ORR) as per local investigator's assessment
Secondary outcome measures
Area under the concentration versus time curve from time zero to time t [AUC0-t]
Characterize the safety and tolerability of zenocutuzumab (MCLA-128)
Clinical Benefit Rate (CBR) of zenocutuzumab (MCLA-128) assessed locally and centrally
+14 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part 2 Solid tumour (basket) harboring NRG1 fusionExperimental Treatment1 Intervention
Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.
Group II: Part 2 Pancreatic adenocarcinoma harboring NRG1 fusionExperimental Treatment1 Intervention
Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.
Group III: Part 2 NSCLC cancer harboring NRG1 fusionExperimental Treatment1 Intervention
Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.
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Who is running the clinical trial?
Merus N.V.Lead Sponsor
7 Previous Clinical Trials
1,115 Total Patients Enrolled
Alison Schram, MDPrincipal InvestigatorMemorial Sloan Kettering Medical Center
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your liver enzyme levels and bilirubin levels should be within certain limits. If you have liver spread of cancer, slightly higher levels are allowed. If you have Gilbert's syndrome, higher bilirubin levels are allowed.I can provide a new or old sample of my tumor for testing.You are expected to live for at least 12 more weeks.I have HIV or untreated Hepatitis B, or I've been treated for Hepatitis C with no detectable virus now.I have brain metastases that are causing symptoms or are unstable.I have a fever or infection that isn't under control.I have heart issues like heart failure, low heart pump function, or serious heart rhythm problems.I had cancer before, but it was treated over 2 years ago.I have at least one tumor that can be measured or my disease can be evaluated in another specific way.I have recovered from major surgery with minimal side effects.My white blood cell count is healthy without needing medication for the past week.I am able to care for myself and perform daily activities.I will use birth control during and for 6 months after the study.I haven't taken any cancer drugs or experimental medications recently.My platelet count is healthy without needing a transfusion in the last week.My cancer is advanced, cannot be surgically removed, and has an NRG1 gene fusion.Your doctor thinks you will live for at least 12 more weeks.Your kidney function is good, with a GFR of more than 30 mL/min.My cancer has spread to the lining of my brain and spinal cord.You are allergic to any of the ingredients in MCLA-128.Side effects from my previous cancer treatments are mild.I have undergone or am considered unsuitable for standard cancer treatments.Your hemoglobin level needs to be at least 8 g/dL or 5 mmol/L.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2 Pancreatic adenocarcinoma harboring NRG1 fusion
- Group 2: Part 2 NSCLC cancer harboring NRG1 fusion
- Group 3: Part 2 Solid tumour (basket) harboring NRG1 fusion
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.
How many participants are being recruited to take part in this experiment?
"To complete this study, 250 suitable candidates are required. Participation can occur at places like Mayo Clinic of Rochester and Karmanos Cancer Center in Detroit."
Answered by AI
Is enrollment open for this clinical research endeavor?
"According to clinicaltrials.gov, the study is currently seeking participants since its original posting on January 1st 2015 and subsequent update on August 10th 2022."
Answered by AI
Is this the inaugural attempt to conduct such an experiment?
"Since 2015, zenocutuzumab (MCLA-128) has been a major focus of scientific research. Merus N.V., who sponsored the inaugural trial in 2015 involving 250 patients, eventually saw their drug receive Phase 2 approval. Currently there are two ongoing trials for this medication distributed across 18 nations and 19 cities respectively."
Answered by AI
How many clinical research centers are carrying out this trial?
"Currently, this medical trial is being conducted out of 13 sites across the continent. Patients can find a clinic in Detroit, Rochester and Toronto as well as 10 other cities to minimize travel strain should they choose to join."
Answered by AI
What kind of safety measures have been taken to ensure people's wellbeing when using zenocutuzumab (MCLA-128)?
"Our team at Power assigned zenocutuzumab (MCLA-128) a score of 2, as the safety profile is supported by evidence from Phase 2 trials, yet there are no studies confirming its efficacy."
Answered by AI
Are there any precedents of research with zenocutuzumab (MCLA-128)?
"Presently, two clinical trials of zenocutuzumab (MCLA-128) are ongoing. While neither is in Phase 3 yet, the research for this therapeutic agent is being conducted at 78 distinct sites across Clermont-Ferrand and California."
Answered by AI
Who else is applying?
What state do they live in?
Washington
What site did they apply to?
The University of Texas MD Anderson Cancer Center
Virginia Mason Hospital & Seattle Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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