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 range18 Years
SexALL
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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.
✓. 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.
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
✕. 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.