Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers

Metastatic Castration-resistant Prostate Cancer Clinical Trial

Official title: A Phase 2 Study Evaluating Activity of Zenocutuzumab (MCLA-128) in Patients With or Without Molecularly Defined Cancers

Status Recruiting

Clinical Trial Summary

This is a Phase II, open-label, 2-arm, multicenter, international study designed to evaluate the efficacy of zenocutuzumab alone or in combination in patients with the following diagnoses:

Group A: NRG1+ NSCLC Group B: mCRPC

Clinical Trial Description

Study Design:

This is an open label (all participants know the identity of the study drug), multicenter (more than one study site), study consisting of 2 parts:

Group A (NRG1+ NSCLC): Approximately 50 NRG1+NSCLC patients will be enrolled and will receive zenocutuzumab in combination with afatinib 40 mg orally once daily.

Group B (mCRPC): Up to 40 mCRPC patients will be enrolled and will receive zenocutuzumab in combination with the AR targeting agent enzalutamide or abiraterone on which they experienced disease progression immediately before study entry.

For the administration of zenocutuzumab in combination in Groups A and B, the Treatment Period will include 2 phases, an initial safety run-in phase, and an expansion phase with an interim efficacy analysis.

The study will consist of 4 periods: Screening, Treatment, Safety Follow-up, and Long-term Follow up. ;

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• NSCLC Harboring NRG1 Fusion
• Prostatic Neoplasms

• NCT number: NCT05588609
• Study type: Interventional
• Source: Merus N.V.
• Contact: Shekeab Jauhari, MD
• Phone: 617-401-4499
• Email: USenquiries@merus.nl
• Status: Recruiting
• Phase: Phase 2
• Start date: November 17, 2022
• Completion date: March 2026