Zenocutuzumab for Non-Small Cell Lung and Prostate Cancers

Recruiting at 7 trial locations

Overseen By Shekeab Jauhari, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merus N.V.

Must be taking: AR signaling inhibitors

Must not be taking: Anti-HER3 therapies, Afatinib

Disqualifiers: CNS metastases, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 9 months

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are in Group B, you must continue ongoing therapy with a next-generation AR signaling inhibitor like enzalutamide or abiraterone, which should have been started at least 90 days before screening.

Eligibility Criteria

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.

Inclusion Criteria

My blood counts and organ functions are within the required ranges.

Signed informed consent before initiation of any study procedures

Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA)

Exclusion Criteria

I do not have active hepatitis B, untreated hepatitis C, or HIV.

I had a heart attack less than 6 months ago.

I have serious heart issues, but not atrial fibrillation or brief, sudden heart palpitations.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zenocutuzumab in combination with afatinib or AR targeting agents, with an initial safety run-in phase followed by an expansion phase

9 months

Intravenous infusion every 2 weeks

Safety Follow-up

Participants are monitored for safety and tolerability of the treatment

6 months

Long-term Follow-up

Participants are monitored for long-term efficacy and survival outcomes

Up to 2 years

Treatment Details

Interventions

• Zenocutuzumab

Trial Overview 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.

Participant Groups

Group I: Part 2: mCRPC Experimental Treatment 3 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+ fusion Experimental Treatment 2 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: mCRPC Experimental Treatment 3 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 IV: Part 1: NSCLC harboring NRG1+ fusion Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Merus N.V.

Lead Sponsor

Trials

10

Recruited

2,700+