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Zenocutuzumab

Clinical trials are studying Zenocutuzumab in people with solid tumors, including tumors with an NRG1 fusion. These trials look at safety, tolerability, and signs of anti-tumor activity. They also measure how long responses last in different patient groups.

Table of contents

Clinical trial overview

The available trial data describe one interventional study of Zenocutuzumab, also listed as MCLA-128, in people with solid tumors.[1] The study is authorised and plans to include 452 participants.[1]

This trial is designed to learn whether the treatment is safe, how well it is tolerated, and whether it shows anti-tumor activity in selected patients.[1]

Who the trials are for

The main study includes patients with solid tumors, which are cancers that form a mass in body tissue.[1] Some trial groups focus on patients whose tumors have an NRG1 fusion, which is a specific gene change found by tumor testing.[1]

The brief summary shows that the trial includes several groups, and the NRG1 fusion groups are used to study anti-tumor activity and how long any response lasts.[1]

Trial phase and study design

This is a Phase 1/2 trial, which means it combines early safety testing with a closer look at whether the treatment may work.[1] The study is interventional, so participants receive the study treatment and researchers measure the results.[1]

In Part 1, the study aims to find the maximum tolerated dose and/or the maximum recommended dose of MCLA-128.[1] These are the dose levels that help researchers decide how much treatment can be given safely.[1]

What the trials measure

The main safety measures in Part 1 are adverse events and dose limiting toxicities.[1] Adverse events are unwanted medical problems during the study, and dose limiting toxicities are side effects that may limit treatment dose.[1]

For Part 2, the study looks at overall response rate, duration of response, and clinical benefit rate in several groups.[1] Overall response rate shows how many patients have tumor shrinkage or disappearance, while duration of response shows how long that benefit lasts.[1]

For the NRG1 fusion groups, the trial also measures overall response rate and duration of response using RECIST v1.1 as assessed by the local investigator.[1] RECIST v1.1 is a standard way to measure tumor changes on scans and exams.[1]

Study groups and patient groups

The study summary divides Part 2 into Groups A to E, F, G, and H, with different goals for each group.[1] Some groups are used to study safety and tolerability, while others are used to explore links between anti-tumor activity and disease-related biomarkers.[1]

For the NRG1 fusion groups, the main focus is on the strength and durability of anti-tumor activity in patients whose tumors carry that fusion.[1] This makes the trial especially relevant for patients with a specific tumor marker rather than all solid tumors.[1]

Trial summary

In the available data, there is one authorised Phase 1/2 trial of Zenocutuzumab in solid tumors, including patients with NRG1 fusion.[1] The study is testing safety, tolerability, dose finding, and early signs of anti-tumor activity.[1] It also measures how long any response lasts and how many patients benefit from treatment.[1]

Trial ID Phase Condition studied Status Enrollment
NCT02912949 Phase 1/2 Solid tumors with NRG1 fusion Authorised 452

FAQ

  • What is being studied in Zenocutuzumab trials? The trials study Zenocutuzumab in patients with solid tumors, including tumors with an NRG1 fusion. Researchers are looking at safety and how well the treatment may work against the cancer.
  • Who may be able to join these trials? The main trial includes patients with solid tumors. Some groups are focused on patients whose tumors have an NRG1 fusion, which is a specific tumor change seen in testing.
  • What phase are the Zenocutuzumab trials? The main study is a Phase 1/2 trial. Phase 1 usually looks at dose and safety, and Phase 2 looks more closely at how well the treatment works.
  • What results are the trials measuring? The trials measure side effects, dose limiting toxicities, overall response rate, duration of response, and clinical benefit rate. These help show both safety and possible anti-tumor activity.
  • How many people are planned for the main study? The main trial lists an enrollment of 452 people. This means up to 452 participants are planned for the study.

Ongoing Clinical Trials on Zenocutuzumab

  • Study of Zenocutuzumab for Patients with Solid Tumors with NRG1 Fusion

    Recruiting

    1 1
    Investigated drugs:
    Austria Belgium Denmark France Germany Italy +4

Glossary

  • Solid tumors: Cancers that form a mass or lump, such as many cancers in organs or tissues.
  • NRG1 fusion: A change in the cancer cells where the NRG1 gene is joined to another gene. This can help identify a specific group of patients for the trial.
  • Phase 1: The first part of a clinical trial. It often studies safety, side effects, and the best dose to use.
  • Phase 2: A later trial stage that looks more closely at whether the treatment shows signs of working.
  • Interventional study: A study where participants receive a treatment or intervention so researchers can see what happens.
  • Adverse events: Unwanted medical problems or side effects that happen during a study.
  • Dose limiting toxicities: Side effects that are serious enough to limit how much of the treatment can be given.
  • Maximum tolerated dose: The highest dose of a treatment that people can take without too many serious side effects.
  • Maximum recommended dose: The dose researchers think is best to move forward with after studying safety.
  • Overall response rate: The number of patients whose cancer shrinks or disappears during treatment.
  • Duration of response: How long a treatment response lasts after it begins.
  • Clinical benefit rate: A measure that includes patients who have a response or stable disease for a meaningful period.

References