Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers (NCT05588609) | Clinical Trial Compass
TerminatedPhase 2
Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers
Stopped: Merus terminated the study early due to changes in organizational priorities.
United States13 participantsStarted 2022-11-17
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent before initiation of any study procedures.
. Age ≥ 18 years at signature of informed consent.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
. Estimated life expectancy of ≥ 12 weeks.
. Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA).
. Adequate organ function:
. Availability of a representative tumor specimen, either a formalin-fixed paraffin embedded (FFPE) de novo (ie, obtained up to 2 months before signing of the informed consent form \[ICF\]) or an FFPE archival tumor sample, preferably collected within 2 years of the start of study treatment. A fresh FFPE sample is preferred.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of response.
Timeframe: Every 8 weeks until study ends, approximately 2 years
2
Group B: Evaluate efficacy of zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of Prostate-Specific antigen level ≥ 50% (PSA50) response.
Timeframe: Every 4 weeks until study ends, approximately 2 years
. Sexually active male and female patients of childbearing potential must agree to use contraceptive measures.
Exclusion criteria
. Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.
. Previous exposure to anti-HER3-directed therapies.
. Known leptomeningeal involvement.
. Participation in another interventional clinical trial or treatment with any investigational drug within 4 weeks before study entry.
. Chronic use of high-dose oral corticosteroid therapy (\> 10 mg of prednisone- equivalent a day).
. History of congestive heart failure Class II-IV by New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, or paroxysmal supraventricular tachycardia).
. History of myocardial infarction within 6 months of study entry.