In short
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.
Key points
- Clinical trials are studying Zenocutuzumab in people with solid tumors, including tumors with an NRG1 fusion. The main trial is a Phase 1/2 study, so it looks at both safety and early signs of how well the treatment may work. Researchers are measuring adverse events, dose limiting toxicities, overall response rate, duration of response, and clinical benefit rate. The trial includes groups of patients with different tumor types, and some groups focus on people with NRG1 fusion. The main study plans to enroll 452 participants and is listed as authorised.
Clinical trial overview
The available trial data describe one interventional study of Zenocutuzumab, also listed as MCLA-128, in people with solid tumors. The study is authorised and plans to include 452 participants.
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.
Who the trials are for
The main study includes patients with solid tumors, which are cancers that form a mass in body tissue. Some trial groups focus on patients whose tumors have an NRG1 fusion, which is a specific gene change found by tumor testing.
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.
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. The study is interventional, so participants receive the study treatment and researchers measure the results.
In Part 1, the study aims to find the maximum tolerated dose and/or the maximum recommended dose of MCLA-128. These are the dose levels that help researchers decide how much treatment can be given safely.
What the trials measure
The main safety measures in Part 1 are adverse events and dose limiting toxicities. Adverse events are unwanted medical problems during the study, and dose limiting toxicities are side effects that may limit treatment dose.
For Part 2, the study looks at overall response rate, duration of response, and clinical benefit rate in several groups. Overall response rate shows how many patients have tumor shrinkage or disappearance, while duration of response shows how long that benefit lasts.
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. RECIST v1.1 is a standard way to measure tumor changes on scans and exams.
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. Some groups are used to study safety and tolerability, while others are used to explore links between anti-tumor activity and disease-related biomarkers.
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. This makes the trial especially relevant for patients with a specific tumor marker rather than all solid tumors.
Trial summary
In the available data, there is one authorised Phase 1/2 trial of Zenocutuzumab in solid tumors, including patients with NRG1 fusion. The study is testing safety, tolerability, dose finding, and early signs of anti-tumor activity. It also measures how long any response lasts and how many patients benefit from treatment.