What side effects are associated with this type of intervention?

Common side effects of monoclonal antibodies targeting HER receptors, such as Zenocutuzumab (MCLA-128), include diarrhea, rash or erythema, and hepatic adverse events. Other frequently observed side effects are fatigue, nausea, and infusion-related reactions. In some cases, more severe adverse events like cardiotoxicity, including heart failure and arrhythmias, may occur, particularly with prolonged treatment.

What prior FDA approvals exist?

Several monoclonal antibodies have been approved by the FDA for the treatment of solid tumors, particularly those targeting the HER family of receptors. Trastuzumab (Herceptin) targets the HER2 receptor and is used in HER2-positive breast and gastric cancers. Pertuzumab (Perjeta), also targeting HER2, is used in combination with trastuzumab for HER2-positive breast cancer. Cetuximab (Erbitux) targets the EGFR receptor and is approved for colorectal cancer and head and neck cancer. These treatments, like Zenocutuzumab (MCLA-128), are designed to target specific receptors involved in tumor growth and proliferation, offering a more personalized approach to cancer therapy.

What other types of research exist?

Promising alternatives to Zenocutuzumab for solid tumors include sacituzumab govitecan, an antibody-drug conjugate active against refractory, metastatic triple-negative breast cancer, and lifastuzumab vedotin, an anti-NaPi2b antibody-drug conjugate for platinum-resistant ovarian cancer. Both are in advanced clinical trials and show potential for broader application in solid tumors.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-12 months

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.

0 / 8Eligibility criteria met

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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