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Monoclonal Antibodies
Zenocutuzumab for Non-Small Cell Lung and Prostate Cancers
Phase 2
Recruiting
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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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
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+ 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
~30
Afatinib Oral Tablet
2019
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
Merus N.V.Lead Sponsor
7 Previous Clinical Trials
1,275 Total Patients Enrolled
1 Trials studying Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood counts and organ functions are within the required ranges.I do not have active hepatitis B, untreated hepatitis C, or HIV.I had a heart attack less than 6 months ago.I am using birth control if I can have children and am sexually active.I have serious heart issues, but not atrial fibrillation or brief, sudden heart palpitations.I take more than 10 mg of prednisone or similar medication daily.I have not had any other cancers in the last 3 years.My brain metastases are either untreated, causing symptoms, or need ongoing treatment.I am fully active or can carry out light work.I am 18 years old or older.I do not have any serious illness or uncontrolled infections.I can provide a recent or fresh tumor sample for the study.My cancer has spread to the lining of my brain and spinal cord.I have been treated with anti-HER3 therapies before.My blood pressure is not higher than 150/100 mmHg and I don't have unstable chest pain.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: mCRPC
- Group 2: Part 1: NSCLC harboring NRG1+ fusion
- Group 3: Part 2: NSCLC harboring NRG1+ fusion
- Group 4: Part 2: mCRPC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks can be associated with mCRPC Phase 1?
"Although there is some evidence of safety, no clinical data exists regarding Part 1: mCRPC efficacy. Thus, it scored a 2 on our team's scale ranging from 1 to 3."
Answered by AI
How many participants have signed up for involvement in this research?
"Affirmative, the information available from clinicaltrials.gov specifies that this scientific trial is still recruiting volunteers to participate. It was first posted on November 17th 2022 and its data set has been updated most recently on the 21st of November 2022. The research necessitates 90 participants at a single site."
Answered by AI
What is the purpose of this experiment?
"This clinical trial seeks to assess the efficacy, safety and tolerability of Zenocutuzumab in combination with Afatinib over a two year period. Primary measurements include response rate, frequency/nature of adverse events (CTCAE Version 5.0), Area Under Curve (AUC0-∞) for afatinib and Progression-Free Survival (PFS) per RECIST v1.1 as determined by local investigators."
Answered by AI
Are there any opportunities currently available to participate in this research?
"Affirmative. According to the information provided on clinicaltrials.gov, this investigation is actively searching for participants and was initially posted on November 17th 2022 with a most recent update occurring four days later."
Answered by AI
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