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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
Must not have
Known symptomatic or unstable brain metastases
Presence of an active uncontrolled infection or an unexplained fever
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 months
Awards & highlights
Summary
This trial is testing a new drug called zenocutuzumab in patients with specific genetic changes in their tumors. The goal is to see if the drug can safely and effectively stop the growth of these cancers.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have brain metastases that are causing symptoms or are unstable.
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I have a fever or infection that isn't under control.
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I have heart issues like heart failure, low heart pump function, or serious heart rhythm problems.
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My cancer has spread to the lining of my brain and spinal cord.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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
+12 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Zenocutuzumab (MCLA-128) is a monoclonal antibody that targets the HER3 receptor, which plays a crucial role in the signaling pathways that drive tumor growth and survival. By binding to HER3, Zenocutuzumab can inhibit these pathways, potentially slowing or stopping tumor progression.
Other common treatments for solid tumors include chemotherapy, which kills rapidly dividing cells; targeted therapies, which interfere with specific molecules involved in tumor growth; and immunotherapy, which enhances the body's immune response against cancer cells. Understanding these mechanisms is vital for patients with solid tumors as it helps in selecting the most effective treatment strategy based on the tumor's specific characteristics and the patient's overall health.
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Who is running the clinical trial?
Merus N.V.Lead Sponsor
9 Previous Clinical Trials
2,638 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.
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