NSCLC Harboring NRG1 FusionPhase 2NCT05588609
Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers
A Phase 2 study testing Afatinib Oral Tablet, Enzalutamide Pill and Abiraterone acetate tablets in people with NSCLC Harboring NRG1 Fusion and Metastatic Castration-resistant Prostate Cancer, run by Partner Therapeutics, Inc. at 7 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Harboring NRG1 Fusion, Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Afatinib Oral Tablet, Enzalutamide Pill and Abiraterone acetate tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 7 sitesUnited States
- Study dates
- 17 Nov 2022to 3 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- Absolute neutrophil count ≥ 1.5 × 109/L.
- Hemoglobin ≥ 9 g/dL.
- Platelets ≥ 100 × 109/L.
- Serum calcium within normal ranges (or corrected with supplements).
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (in case of liver involvement by malignancy, ALT/AST ≤ 5 × ULN will be allowed).
- Total bilirubin ≤ 1.5 × ULN (in case of Gilbert disease, total bilirubin ≤ 3 × ULN will be allowed).
- Estimated glomerular filtration rate of > 30 mL/min based on the Cockroft-Gault formula (Appendix D).
- Serum albumin > 3.0 g/dL.
- 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.
- A1. Have histologically confirmed locally advanced, unresectable, or metastatic NSCLC harboring an NRG1 gene fusion detected by DNA- or RNA-based next generation sequencing in a tumor sample or in plasma-cell free DNA. A2. Have received prior standard therapy appropriate for the tumor type and disease or must be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy in the opinion of the Investigator or have no satisfactory available treatment options. A3. Have at least 1 measurable lesion per RECIST v1.1. A4. Able to swallow oral medications and absence of gastrointestinal conditions (eg, malabsorption, resection) deemed to jeopardize intestinal absorption.
- Inclusion Criteria: (Group B Only) B1. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features. B2. Metastatic disease documented by at least 2 bone lesions on whole body bone scintigraphy, or soft tissue disease documented by computed tomography (CT) scan/magnetic resonance imaging (MRI). B3. Ongoing androgen deprivation with a serum testosterone level ≤ 1.73 nmol/L (≤ 50 ng/dL) at Screening. B4. Current ongoing therapy with a next-generation AR signaling inhibitor (enzalutamide or abiraterone) started at least 90 days before Screening. B5. Progressive disease by PCWG3 criteria B6. Able to swallow oral medications and absence of gastrointestinal conditions (eg, malabsorption, resection) deemed to jeopardize intestinal absorption.
Who cannot join
- 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).
- Uncontrolled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg) or unstable angina.
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- 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.
- History of prior or concomitant malignancies (other than excised nonmelanoma skin cancer, cured in situ cervical carcinoma, or low-grade Ta or T1 urothelial carcinoma of the bladder that has undergone potentially curative therapy) within 3 years of study entry.
- Current serious illness or medical conditions including, but not limited to uncontrolled active infection, and clinically significant pulmonary, metabolic, or psychiatric disorders.
- Patients with the following known infectious diseases:
- Known active hepatitis B infection (hepatitis B surface antigen [HBsAg] positive) without receiving antiviral treatment.
- Known positive test for hepatitis C virus (HCV) RNA.
- Known human immunodeficiency virus (HIV)-positive patients unless the CD4+ count is ≥ 300/μL, viral load is undetectable, and the patient is currently receiving highly active antiretroviral therapy.
- Exclusion Criteria: (Group A) A1. Patients previously exposed to afatinib. A2. History of interstitial lung disease (ILD), ILD-like adverse reactions (such as lung infiltration, pneumonitis, acute respiratory distress syndrome, allergic alveolitis), or radiation pneumonia requiring steroid therapy.
- Exclusion Criteria: (Group B) B1. More than 2 lines of a second-generation hormonal agent for metastatic disease.
- B2. More than 2 lines of systemic chemotherapy for metastatic disease. B3. Patients with only nonmeasurable lesions other than bone metastasis (eg, pleural effusion, ascites, other visceral locations). B4. A history of seizure or any condition predisposing patient to seizure within 12 months before study treatment, including history of unexplained loss of consciousness or transient ischemic attack, for patients receiving enzalutamide.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
The Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
TriHealth Cancer Institute
Cincinnati, Ohio, 45220
University Hospitals - Seidman Cancer Center
Cleveland, Ohio, 44106
Florida Cancer Specialists
Lake Mary, Florida, 32746
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Northwest Medical Specialties
Tacoma, Washington, 98405
The Oncology Institute of Hope & Innovation
Whittier, California, 90603
About this study
Official title: A Phase 2 Study Evaluating Activity of Zenocutuzumab (MCLA-128) in Patients With or Without Molecularly Defined Cancers
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
Read the detailed description
Study Design:
This is an open label (all participants know the identity of the study drug), multicenter (more than one study site), study consisting of 2 parts:
Group A (NRG1+ NSCLC): Approximately 50 NRG1+NSCLC patients will be enrolled and will receive zenocutuzumab in combination with afatinib 40 mg orally once daily.
Group B (mCRPC): Up to 40 mCRPC patients will be enrolled and will receive zenocutuzumab in combination with the AR targeting agent enzalutamide or abiraterone on which they experienced disease progression immediately before study entry.
For the administration of zenocutuzumab in combination in Groups A and B, the Treatment Period will include 2 phases, an initial safety run-in phase, and an expansion phase with an interim efficacy analysis.
The study will consist of 4 periods: Screening, Treatment, Safety Follow-up, and Long-term Follow up.
- Being tested
- Afatinib Oral Tablet, Enzalutamide Pill, Abiraterone acetate tablets, MCLA-128
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afatinib Oral TabletDrug
Also called GILOTRIF®, GIOTRIF®
anti epidermal growth factor receptor (EGFR)/HER2 agent
Enzalutamide PillDrug
Also called XTANDI®
second-generation androgen receptor antagonist
Abiraterone acetate tabletsDrug
Also called ZYTIGA®
androgen synthesis inhibitor
MCLA-128Biological
Also called Zenocutuzumab
full length IgG1 bispecific antibody targeting HER2 and HER3
| Study group | Role | What they receive |
|---|---|---|
| Part 1: NSCLC harboring NRG1+ fusion | Experimental | Participants will receive intravenous infusion of 750 mg of zenocutuzumab once every 2 weeks in combination with afatinib 40 mg orally once daily. Receives: Drug: Afatinib Oral Tablet; Biological: MCLA-128 |
| Part 1: mCRPC | Experimental | 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. Receives: Drug: Enzalutamide Pill; Drug: Abiraterone acetate tablets; Biological: MCLA-128 |
| Part 2: NSCLC harboring NRG1+ fusion | Experimental | Participants will receive intravenous infusion of 750 mg of zenocutuzumab once every 2 weeks in combination with afatinib 40 mg orally once daily. Receives: Drug: Afatinib Oral Tablet; Biological: MCLA-128 |
| Part 2: mCRPC | Experimental | 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 Receives: Drug: Enzalutamide Pill; Drug: Abiraterone acetate tablets; Biological: MCLA-128 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of response.
Objective Response Rate (ORR) by local assessment per RECIST v1.1
Measured: Every 8 weeks until study ends, approximately 2 years
Group B: Evaluate efficacy of zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of Prostate-Specific antigen level ≥ 50% (PSA50) response.
PSA50 response rate
Measured: Every 4 weeks until study ends, approximately 2 years
Secondary outcomes (25)
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by local investigator
Objective Response Rate (ORR) per RECIST v1.1
Measured: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by local investigator
Duration of Response (DOR) per RECIST v1.1
Measured: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by local investigator
Time to Response (TTR) per RECIST v1.1
Measured: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by independent central review
Objective Response Rate (ORR) per RECIST v1.1
Measured: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by independent central review
Duration of Response (DOR) per RECIST v1.1
Measured: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by independent central review
Time to Response (TTR) per RECIST v1.1
Measured: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by independent central review
Progression-free Survival (PFS) per RECIST v1.1
Measured: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by local investigator
Progression-free Survival (PFS) per RECIST v1.1
Measured: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of survival
Overall Survival (OS)
Measured: Continuous through study completion, up to 2 years
Group A: Evaluate safety and tolerability of zenocutuzumab in combination with afatinib
Frequency and nature of adverse events (AEs) that are related to treatment as assessed by Common Terminology Criteria for AEs (CTCAE) version 5.0
Measured: continuous through study completion, an average of 9 months
Group A: Maximum plasma concentration [Cmax] of zenocutuzumab when given in combination with afatinib
Cmax
Measured: 12 months
Group A: Characterize immunogenicity of zenocutuzumab.
Incidence of antidrug antibodies against zenocutuzumab
Measured: 12 months
Group A: Area under the concentration versus time curve from time zero to time t [AUC0-t] of zenocutuzumab when given in combination with afatinib
AUC0-t
Measured: 12 months
Group A: Area under the concentration versus time curve [AUC0-∞] of zenocutuzumab when given in combination with afatinib
AUC0-∞
Measured: 12 months
Group A: Area under the concentration versus time curve [AUC0-∞] of afatinib when given in combination with zenocutuzumab
AUC0-∞
Measured: 12 months
Group A: Area under the concentration versus time curve from time zero to time t [AUC0-t] afatinib when given in combination with zenocutuzumab
AUC0-t
Measured: 12 months
Group A: Maximum plasma concentration [Cmax] afatinib when given in combination with zenocutuzumab
Cmax
Measured: 12 months
Group A: Characterize immunogenicity of zenocutuzumab.
Serum titers of antidrug antibodies against zenocutuzumab
Measured: 12 months
Group B: Evaluate efficacy of zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of antitumor activity as assessed by local investigator.
Objective Response Rate (ORR) per RECIST v1.1
Measured: Every 8 weeks until study ends, approximately 2 years
Group B: Evaluate efficacy of zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of Prostate-specific antigen level ≥ 30% (PSA30) response.
PSA30 response rate
Measured: Every 4 weeks until study ends, approximately 2 years
Group B: Evaluate efficacy zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of survival parameters
Radiographic Progression Free Survival (rPFS) by local investigator per Prostate Cancer Clinical Trials Working Group 3 Modified Response Evaluation Criteria in Solid Tumors (PCWG3-modified RECIST) v1.1 and Overall Survival (OS)
Measured: Continuous through study completion, up to 2 years
Group B: Evaluate efficacy of zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of antitumor activity as assessed by local investigator.
Duration of Response (DOR) per PCWG3-modified RECIST v1.1
Measured: Every 8 weeks until study ends, approximately 2 years
Group B: Evaluate efficacy of zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of antitumor activity as assessed by local investigator.
Time to Response (TTR) per PCWG3-modified RECIST v1.1
Measured: Every 8 weeks until study ends, approximately 2 years
Group B: Evaluate efficacy of zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of Prostate-specific antigen level ≥ 30% (PSA30) response.
time to Prostate-specific antigen (PSA) progression per PCWG3-modified RECIST v1.1
Measured: Every 8 weeks until study ends, approximately 2 years
Group B: Evaluate safety and tolerability of zenocutuzumab in combination with enzalutamide or abiraterone acetate.
Frequency and nature of adverse events (AEs) that are related to treatment as assessed by Common Terminology Criteria for AEs (CTCAE) version 5.0
Measured: continuous through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start17 Nov 2022
- Primary completion3 Jul 2025
- Study completion3 Jul 2025
Why it stopped: Merus terminated the study early due to changes in organizational priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Harboring NRG1 FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Partner Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588609
- Sponsor's protocol ID
- MCLA-128-CL03
- Status last verified
- Apr 2026
- First submitted
- 14 Oct 2022
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Evaluating Activity of Zenocutuzumab (MCLA-128) in Patients With or Without Molecularly Defined Cancers
- ClinicalTrials.gov ID
- NCT05588609
- Acronym / sponsor ID
- MCLA-128-CL03
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Merus terminated the study early due to changes in organizational priorities.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Partner Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Study Design:
This is an open label (all participants know the identity of the study drug), multicenter (more than one study site), study consisting of 2 parts:
Group A (NRG1+ NSCLC): Approximately 50 NRG1+NSCLC patients will be enrolled and will receive zenocutuzumab in combination with afatinib 40 mg orally once daily.
Group B (mCRPC): Up to 40 mCRPC patients will be enrolled and will receive zenocutuzumab in combination with the AR targeting agent enzalutamide or abiraterone on which they experienced disease progression immediately before study entry.
For the administration of zenocutuzumab in combination in Groups A and B, the Treatment Period will include 2 phases, an initial safety run-in phase, and an expansion phase with an interim efficacy analysis.
The study will consist of 4 periods: Screening, Treatment, Safety Follow-up, and Long-term Follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Part 1: NSCLC harboring NRG1+ fusion | Experimental | Drug: Afatinib Oral Tablet, Biological: MCLA-128Participants will receive intravenous infusion of 750 mg of zenocutuzumab once every 2 weeks in combination with afatinib 40 mg orally once daily. |
| Part 1: mCRPC | Experimental | Drug: Enzalutamide Pill, Drug: Abiraterone acetate tablets, Biological: MCLA-128Participants 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. |
| Part 2: NSCLC harboring NRG1+ fusion | Experimental | Drug: Afatinib Oral Tablet, Biological: MCLA-128Participants will receive intravenous infusion of 750 mg of zenocutuzumab once every 2 weeks in combination with afatinib 40 mg orally once daily. |
| Part 2: mCRPC | Experimental | Drug: Enzalutamide Pill, Drug: Abiraterone acetate tablets, Biological: MCLA-128Participants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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).
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afatinib Oral TabletAlso: GILOTRIF®, GIOTRIF®anti epidermal growth factor receptor (EGFR)/HER2 agent | Drug | Part 1: NSCLC harboring NRG1+ fusion, Part 2: NSCLC harboring NRG1+ fusion |
| Enzalutamide PillAlso: XTANDI®second-generation androgen receptor antagonist | Drug | Part 1: mCRPC, Part 2: mCRPC |
| Abiraterone acetate tabletsAlso: ZYTIGA®androgen synthesis inhibitor | Drug | Part 1: mCRPC, Part 2: mCRPC |
| MCLA-128Also: Zenocutuzumabfull length IgG1 bispecific antibody targeting HER2 and HER3 | Biological | Part 1: NSCLC harboring NRG1+ fusion, Part 1: mCRPC, Part 2: NSCLC harboring NRG1+ fusion, Part 2: mCRPC |
Primary outcome
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of response.
Time frame: Every 8 weeks until study ends, approximately 2 years
Objective Response Rate (ORR) by local assessment per RECIST v1.1
Group B: Evaluate efficacy of zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of Prostate-Specific antigen level ≥ 50% (PSA50) response.
Time frame: Every 4 weeks until study ends, approximately 2 years
PSA50 response rate
25 secondary outcomes
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by local investigator
Time frame: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by local investigator
Time frame: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by local investigator
Time frame: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by independent central review
Time frame: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by independent central review
Time frame: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by independent central review
Time frame: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by independent central review
Time frame: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of antitumor activity as assessed by local investigator
Time frame: Every 8 weeks until study ends, approximately 2 years
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of survival
Time frame: Continuous through study completion, up to 2 years
Group A: Evaluate safety and tolerability of zenocutuzumab in combination with afatinib
Time frame: continuous through study completion, an average of 9 months
Group A: Maximum plasma concentration [Cmax] of zenocutuzumab when given in combination with afatinib
Time frame: 12 months
Group A: Characterize immunogenicity of zenocutuzumab.
Time frame: 12 months
Group A: Area under the concentration versus time curve from time zero to time t [AUC0-t] of zenocutuzumab when given in combination with afatinib
Time frame: 12 months
Group A: Area under the concentration versus time curve [AUC0-∞] of zenocutuzumab when given in combination with afatinib
Time frame: 12 months
Group A: Area under the concentration versus time curve [AUC0-∞] of afatinib when given in combination with zenocutuzumab
Time frame: 12 months
Group A: Area under the concentration versus time curve from time zero to time t [AUC0-t] afatinib when given in combination with zenocutuzumab
Time frame: 12 months
Group A: Maximum plasma concentration [Cmax] afatinib when given in combination with zenocutuzumab
Time frame: 12 months
Group A: Characterize immunogenicity of zenocutuzumab.
Time frame: 12 months
Group B: Evaluate efficacy of zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of antitumor activity as assessed by local investigator.
Time frame: Every 8 weeks until study ends, approximately 2 years
Group B: Evaluate efficacy of zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of Prostate-specific antigen level ≥ 30% (PSA30) response.
Time frame: Every 4 weeks until study ends, approximately 2 years
Group B: Evaluate efficacy zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of survival parameters
Time frame: Continuous through study completion, up to 2 years
Group B: Evaluate efficacy of zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of antitumor activity as assessed by local investigator.
Time frame: Every 8 weeks until study ends, approximately 2 years
Group B: Evaluate efficacy of zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of antitumor activity as assessed by local investigator.
Time frame: Every 8 weeks until study ends, approximately 2 years
Group B: Evaluate efficacy of zenocutuzumab in combination with enzalutamide or abiraterone acetate in terms of Prostate-specific antigen level ≥ 30% (PSA30) response.
Time frame: Every 8 weeks until study ends, approximately 2 years
Group B: Evaluate safety and tolerability of zenocutuzumab in combination with enzalutamide or abiraterone acetate.
Time frame: continuous through study completion, an average of 6 months
Results and safety
The study was stopped early (reason given: Merus terminated the study early due to changes in organizational priorities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for NSCLC Harboring NRG1 Fusion
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Active, not recruitingPhase 1
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Afatinib Oral Tablet, Enzalutamide Pill and Abiraterone acetate tablets in people with NSCLC Harboring NRG1 Fusion and Metastatic Castration-resistant Prostate Cancer, run by Partner Therapeutics, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Merus terminated the study early due to changes in organizational priorities.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group A: Evaluate efficacy of zenocutuzumab in combination with afatinib in terms of response. (time frame: Every 8 weeks until study ends, approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.