Spots Global Cancer Trial Database for Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers

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Trial Identification

Brief Title: Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers

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

Study ID: NCT05588609

Conditions

NSCLC Harboring NRG1 Fusion

Metastatic Castration-resistant Prostate Cancer

Interventions

Afatinib Oral Tablet

Enzalutamide Pill

Abiraterone acetate tablets

MCLA-128

Study Description

Brief 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

Detailed 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.