Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, For A Patient With Advanced NRG1-Fusion Positive Solid Tumor

Study Overview

Early Access Program Providing 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.

N/A

NRG1 Fusion
Pancreatic Cancer
Non Small Cell Lung Cancer
Solid Tumor, Unspecified, Adult
Prostate Cancer
Head and Neck Cancer
Colorectal Cancer
Breast Cancer
Cholangiocarcinoma
Renal Cell Carcinoma
Unknown Primary Tumors

DRUG: MCLA-128

MCLA-128-CL99; MCLA-128-CL98

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-09-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-15
First Submitted that Met QC Criteria 2019-09-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-20
First Posted (ACTUAL) 2019-09-24	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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
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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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