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Monoclonal Antibodies

Zenocutuzumab for Non-Small Cell Lung and Prostate Cancers

Phase 2

Waitlist Available

Research Sponsored by Merus N.V.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks until study ends, approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug to treat lung and prostate cancers.

Who is the study for?

Adults with specific cancers (NRG1+ NSCLC or mCRPC) who have tried standard treatments without success, or those for whom standard treatments are not suitable. Participants must be in good physical condition, with a life expectancy of at least 12 weeks and normal heart function. They should have no serious infections like hepatitis B/C or HIV, no recent heart attacks, and must agree to use contraception.

What is being tested?

The trial is testing Zenocutuzumab alone or combined with other cancer drugs (Afatinib, Enzalutamide, Abiraterone acetate) on patients with NRG1+ non-small cell lung cancer (NSCLC) or metastatic castration-resistant prostate cancer (mCRPC). It's an open-label study where everyone knows what treatment they're getting.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in different organs; gastrointestinal issues; fatigue; blood-related problems like changes in counts of white cells, red cells, and platelets which could affect immunity and oxygen transport; liver enzyme alterations indicating potential liver damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 8 weeks until study ends, approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 8 weeks until study ends, approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks until study ends, approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of response.

Group B: Evaluate efficacy of zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of Prostate-Specific antigen level ≥ 50% (PSA50) response.

Secondary study objectives

Group A: Area under the concentration versus time curve [AUC0-∞] of afatinib when given in combination with zenocutuzumab

Afatinib

Group A: Area under the concentration versus time curve from time zero to time t [AUC0-t] afatinib when given in combination with zenocutuzumab

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2: mCRPCExperimental Treatment3 Interventions

Participants will receive intravenous infusion of 750 mg of zenocutuzumab once every 2 weeks in combination with the AR targeting agent they experienced disease progression on prior to study entry: enzalutamide 160 mg orally once daily or abiraterone 1000 mg orally once daily with prednisone 5 mg orally twice daily

Group II: Part 2: NSCLC harboring NRG1+ fusionExperimental Treatment2 Interventions

Participants will receive intravenous infusion of 750 mg of zenocutuzumab once every 2 weeks in combination with afatinib 40 mg orally once daily.

Group III: Part 1: mCRPCExperimental Treatment3 Interventions

Group IV: Part 1: NSCLC harboring NRG1+ fusionExperimental Treatment2 Interventions

Participants will receive intravenous infusion of 750 mg of zenocutuzumab once every 2 weeks in combination with afatinib 40 mg orally once daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abiraterone acetate tablets

2011

Completed Phase 1