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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~6-12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-12 months for reporting.

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 more

Trial 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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Find a Location

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

Zenocutuzumab (MCLA-128) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02912949 — Phase 2
Solid Tumors Research Study Groups: Part 2 Pancreatic adenocarcinoma harboring NRG1 fusion, Part 2 NSCLC cancer harboring NRG1 fusion, Part 2 Solid tumour (basket) harboring NRG1 fusion
Solid Tumors Clinical Trial 2023: Zenocutuzumab (MCLA-128) Highlights & Side Effects. Trial Name: NCT02912949 — Phase 2
Zenocutuzumab (MCLA-128) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02912949 — Phase 2
~45 spots leftby Dec 2026