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Study of Zenocutuzumab for Patients with Solid Tumors with NRG1 Fusion

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a treatment for patients with solid tumors, which are abnormal masses of tissue that can occur in various parts of the body. The treatment being tested is called Zenocutuzumab, also known by its code name MCLA-128. Zenocutuzumab is a type of medication known as a bispecific antibody, which is designed to target specific proteins called HER2 and HER3 that are found on the surface of some cancer cells. This study is particularly interested in patients whose tumors have a specific genetic change called an NRG1 fusion.

The purpose of the study is to understand how safe and tolerable Zenocutuzumab is for patients and to explore how it interacts with the cancer. The study is divided into two parts. In the first part, researchers aim to find the best dose of Zenocutuzumab that patients can tolerate. In the second part, the focus is on understanding the safety of the treatment and how well it works against the cancer, especially in patients with the NRG1 fusion. Patients will receive Zenocutuzumab through an infusion, which means the medication is given directly into the bloodstream through a vein.

Throughout the study, researchers will monitor patients for any side effects and assess how the cancer responds to the treatment. The study will also look at how long the treatment effects last in patients with the NRG1 fusion. This research is important for developing new treatments for solid tumors and could provide valuable information on how Zenocutuzumab works in these specific types of cancer. Participants will be closely observed by healthcare professionals to ensure their safety and to gather detailed information about the treatment's effects.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A blood test is performed to ensure that laboratory values meet the study's requirements. A tumor biopsy sample is also collected if safe and feasible.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of zenocutuzumab (MCLA-128), a solution for infusion given intravenously.

    The dosage and frequency are determined based on the study's phase and the patient's group assignment.

  3. Step 3

    Monitoring and evaluation

    Regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes evaluating any adverse events and dose-limiting toxicities.

    The anti-tumor activity is assessed through imaging studies and other relevant tests to determine the overall response rate and duration of response.

  4. Step 4

    Follow-up

    After completing the treatment phase, follow-up visits are scheduled to monitor the patient's health and any long-term effects of the treatment.

    The follow-up period includes assessments of progression-free survival and overall survival.

Who can join the trial?

15 criteria

  • Must be at least 18 years old.
  • Women of childbearing potential must have a negative pregnancy test before starting the study and within 7 days of the first treatment cycle.
  • Sexually active men and women of childbearing potential must agree to use effective birth control during the study and for 6 months after the last dose of the study drug.
  • Must be able to provide written consent to participate in the study, understanding that they can withdraw at any time.
  • Must understand and be willing to follow the study procedures and requirements.
  • Must have received standard treatment for their type and stage of cancer, or there are no other suitable treatment options available.
  • Must have a specific type of cancer called a **solid tumor** with a documented **NRG1 gene fusion**, which is a specific genetic change in the tumor.
  • Must have at least one measurable tumor or disease that can be evaluated.
  • Must have an **ECOG** performance status of 0, 1, or 2, which is a scale used to assess how well a patient can perform daily activities.
  • Must have a life expectancy of at least 12 weeks.
  • Any side effects from previous cancer treatments must be resolved to a mild level, except for hair loss or mild nerve damage.
  • Must have stopped any previous cancer treatments within a certain time frame before starting the study drug.
  • Must have recovered from any previous surgeries or procedures to a mild level or baseline condition.
  • Must have certain laboratory test results within normal ranges, such as blood cell counts and liver and kidney function tests.
  • Must be able to provide a tumor biopsy sample at the start of the study, either a new sample or an older one if a new sample is not possible.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied, which is called solid tumors.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have a medical condition that might make it unsafe for them to participate in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent major surgery or are recovering from one.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of severe allergic reactions to similar medications.
  • Patients who have a condition that affects their immune system, making them more vulnerable to infections.
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Investigated drugs

MCLA-128 is a bispecific antibody designed to target two proteins, HER2 and HER3, which are often involved in the growth of certain types of cancer cells. This medication is being studied to determine the best dose that can be given safely to patients and to understand how well it works in treating solid tumors. The trial aims to see how effective MCLA-128 is in reducing tumor size and how long its effects last, especially in patients with specific genetic changes known as NRG1 fusions.

What is already known about the treatment

MCLA-128 – MCLA-128 is administered intravenously and is currently being studied in clinical trials for its potential use in treating solid tumors. It is a bispecific antibody that targets HER2 and HER3 receptors, which are proteins involved in the growth of certain types of cancer cells. By binding to these receptors, MCLA-128 can inhibit cancer cell growth and survival. It is classified as a monoclonal antibody and is being evaluated for its safety, tolerability, and effectiveness in patients with specific genetic markers, such as NRG1 fusions.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs and bones. These tumors are characterized by the uncontrolled growth of cells that form a solid mass. As they progress, they may invade nearby tissues and organs, potentially causing physical symptoms depending on their location. Solid tumors can be benign, meaning they do not spread to other parts of the body, or malignant, which means they have the potential to spread and invade other tissues. The progression of solid tumors varies widely depending on the type and location of the tumor.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-512358-78-00Protocol codeMCLA-128-CL01Estimated enrolment452 patientsSponsorPartner Therapeutics Inc.

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