NRG1 FusionNCT04100694
Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor
A study testing MCLA-128 in people with NRG1 Fusion and Pancreatic Cancer, run by Merus B.V..
Trial summary
Merus is providing single patient/named access to the HER2/HER3 bispecific antibody, MCLA-128, to patients with advanced NRG1-fusion positive solid tumor under this early access program who are ineligible for an ongoing MCLA-128 clinical trial or have other considerations that prevent access to MCLA-128 through an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NRG1 Fusion, Pancreatic Cancer, Non Small Cell Lung Cancer
- What is being tested?
- MCLA-128
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- At least one evaluable or measurable lesion according to RECIST v1.1
- Patient with advanced metastatic solid tumor with documented NRG1 fusion determined in a qualified local laboratory by molecular profiling using methods such as next generation sequencing [DNA or RNA] as routinely performed at CLIA or other similarly-certified laboratories.
- Treatment with anticancer medications or investigational drugs within the following intervals before the first administration of MCLA-128:
- At least 14 days for chemotherapy, targeted small molecule therapy, or radiation therapy OR
- At least 5 half-lives have passed since discontinuation of the systemic treatment
Show all 12Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate organ function at the time of initiation of treatment administration
- Negative pregnancy test results in women of childbearing potential (defined as women ≤50 years of age or history of amenorrhea for ≤12 months prior to study entry)
- Ability to give written, informed consent prior to treatment, with the understanding that the consent may be withdrawn by the patient at any time without prejudice
- Not eligible or feasible to participate in a clinical trial
- Any condition that in the opinion of Merus may preclude appropriate use of the investigational medicine
Who cannot join
- Any untreated, symptomatic central nervous system (CNS) lesion
- Presence of an active and uncontrolled infection
- Leptomeningeal metastases
- Known hypersensitivity to any of the components of MCLA-128 or history of severe hypersensitivity reactions to human or humanized monoclonal antibodies, including therapeutic antibodies
- Presence of LVEF <50% on the screening echocardiogram; or history or presence of any significant cardiovascular disease, including unstable angina or myocardial infarction within 12 months prior to treatment, congestive heart failure (NYHA Class III or IV), or ventricular arrhythmia requiring medication
- Presence of any other medical or psychological condition deemed by the Physician to be likely to interfere with a patient's ability to sign informed consent, cooperate or participate in the study, or interfere with the interpretation of the results.
About this study
Official title: Treatment Plan of the HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor
Merus is providing single patient/named access to the HER2/HER3 bispecific antibody, MCLA-128, to patients with advanced NRG1-fusion positive solid tumor under this early access program who are ineligible for an ongoing MCLA-128 clinical trial or have other considerations that prevent access to MCLA-128 through an existing clinical trial. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual's medical history and program eligibility criteria.
- Conditions
- NRG1 Fusion, Pancreatic Cancer, Non Small Cell Lung Cancer, Solid Tumor, Unspecified, Adult, Prostate Cancer, Head and Neck Cancer
- Being tested
- MCLA-128
- Keywords
- Early Access, NRG1 fusion, Pancreas cancer, Non Small Cell Lung Cancer, Solid tumor, Compassionate use, Expanded access
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms, Head and Neck Neoplasms, Colorectal Neoplasms, Breast Neoplasms, Cholangiocarcinoma, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCLA-128Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Merus B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100694
- Sponsor's protocol ID
- MCLA-128-CL99; MCLA-128-CL98
- Status last verified
- Apr 2025
- First submitted
- 20 Sep 2019
- Last updated
- 20 May 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Plan of the HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor
- ClinicalTrials.gov ID
- NCT04100694
- Acronym / sponsor ID
- MCLA-128-CL99; MCLA-128-CL98
- Conditions
- NRG1 Fusion, Pancreatic Cancer, Non Small Cell Lung Cancer, Solid Tumor, Unspecified, Adult, Prostate Cancer, Head and Neck Cancer
- Keywords
- Early Access, NRG1 fusion, Pancreas cancer, Non Small Cell Lung Cancer, Solid tumor, Compassionate use, Expanded access
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Merus B.V.Industry (pharma, biotech, devices)
- First posted
- 24 Sep 2019 (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.
Merus is providing single patient/named access to the HER2/HER3 bispecific antibody, MCLA-128, to patients with advanced NRG1-fusion positive solid tumor under this early access program who are ineligible for an ongoing MCLA-128 clinical trial or have other considerations that prevent access to MCLA-128 through an existing clinical trial. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual's medical history and program eligibility criteria.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 years or older
- At least one evaluable or measurable lesion according to RECIST v1.1
- Patient with advanced metastatic solid tumor with documented NRG1 fusion determined in a qualified local laboratory by molecular profiling using methods such as next generation sequencing [DNA or RNA] as routinely performed at CLIA or other similarly-certified laboratories.
- Treatment with anticancer medications or investigational drugs within the following intervals before the first administration of MCLA-128:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Key exclusion criteria (6 listed)
- Any untreated, symptomatic central nervous system (CNS) lesion
- Presence of an active and uncontrolled infection
- Leptomeningeal metastases
- Known hypersensitivity to any of the components of MCLA-128 or history of severe hypersensitivity reactions to human or humanized monoclonal antibodies, including therapeutic antibodies
- Presence of LVEF <50% on the screening echocardiogram; or history or presence of any significant cardiovascular disease, including unstable angina or myocardial infarction within 12 months prior to treatment, congestive heart failure (NYHA Class III or IV), or ventricular arrhythmia requiring medication
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 |
|---|---|---|
| MCLA-128 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
Related trials for NRG1 Fusion
RecruitingPhase 1
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer
Enrolling by invitationObservational study
Integrated Genomics in Oncogene-driven NSCLC With Acquired Resistance
Oncogene-addicted Non Small Cell Lung Cancer, EGFR Mutation
RecruitingPhase 2
Patritumab Deruxtecan in Patients With Solid Tumor Harboring an NRG1 Fusion
Solid Tumor, Adult
Active, not recruitingPhase 1/2
A Phase I/IIa Trial of HMBD-001 in Advanced HER3 Positive Solid Tumours
Bladder Cancer, Triple Negative Breast Cancer
Active, not recruitingPhase 2
A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)
Solid Tumours Harboring NRG1 Fusion, NSCLC Harboring NRG1 Fusion
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.
Questions about this trial
What is this clinical trial studying?
A study testing MCLA-128 in people with NRG1 Fusion and Pancreatic Cancer, run by Merus B.V..
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 12 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
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.
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 20 May 2025.