Study on Zenocutuzumab for Patients with Specific Types of Cancer

Sponsor: Merus N.V.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05588609

Provider View

This clinical trial is testing the effectiveness of the drug zenocutuzumab, either alone or in combination with other treatments, in patients with certain types of cancer, including NRG1+ non-small cell lung cancer (NSCLC) and metastatic castration-resistant prostate cancer (mCRPC).

Patient Parameters

Program Overview

This study is designed to evaluate how well zenocutuzumab works in treating patients with specific types of cancer. It includes two groups: Group A for patients with NRG1+ non-small cell lung cancer (NSCLC) and Group B for patients with metastatic castration-resistant prostate cancer (mCRPC). The study will take place at multiple locations internationally and will involve different phases to assess safety and effectiveness.

Description

The study is divided into two main groups:

  • Group A (NRG1+ NSCLC): About 50 patients with NRG1+ non-small cell lung cancer will receive zenocutuzumab combined with the drug afatinib, taken orally once a day.

  • Group B (mCRPC): Up to 40 patients with metastatic castration-resistant prostate cancer will receive zenocutuzumab along with either enzalutamide or abiraterone, which they were taking before joining the study.

The study includes several phases:

  1. Screening: Initial assessments to determine eligibility.
  2. Treatment: Patients receive the study drugs.
  3. Safety Follow-up: Monitoring for any side effects.
  4. Long-term Follow-up: Ongoing checks to see how patients are doing over time.

The study aims to find out if zenocutuzumab can help control these cancers and improve patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a good performance status (able to carry out daily activities with minimal restrictions).
  • Must have a life expectancy of at least 12 weeks.
  • Must have adequate heart function and organ health based on specific medical tests.
  • Must provide a tumor sample for analysis.
  • Must agree to use contraception if sexually active.

For Group A (NRG1+ NSCLC):

  • Must have advanced or metastatic NSCLC with an NRG1 gene fusion.
  • Must have tried standard treatments or have no other suitable options.
  • Must have at least one measurable tumor.
  • Must be able to take oral medications.

For Group B (mCRPC):

  • Must have prostate cancer without certain cell features.
  • Must have metastatic disease confirmed by scans.
  • Must be on ongoing hormone therapy with low testosterone levels.
  • Must be taking enzalutamide or abiraterone for at least 90 days before the study.
  • Must have progressive disease based on specific criteria.
  • Must be able to take oral medications.

Exclusion Criteria

  • Have untreated or symptomatic brain metastases.
  • Have previously received anti-HER3 therapies.
  • Have certain other cancers or medical conditions that could interfere with the study.
  • Have uncontrolled high blood pressure or heart problems.
  • Have active infections like hepatitis B, hepatitis C, or HIV unless well-controlled.

For Group A (NRG1+ NSCLC):

  • Have previously taken afatinib.
  • Have a history of lung diseases requiring steroids.

For Group B (mCRPC):

  • Have had more than two lines of certain hormonal or chemotherapy treatments for metastatic disease.
  • Have only non-measurable tumors other than bone metastases.
  • Have a history of seizures or conditions that could lead to seizures.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.