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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04100694
Expanded Access Status : Available
First Posted : September 24, 2019
Last Update Posted : July 28, 2021
Information provided by (Responsible Party):
Merus N.V.

Brief 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 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.

Condition or disease Intervention/treatment
NRG1 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

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Treatment Plan of the HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • 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] or FISH 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:

    1. At least 14 days for chemotherapy, targeted small molecule therapy, or radiation therapy OR
    2. At least 5 half-lives have passed since discontinuation of the systemic treatment
  • 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

Exclusion Criteria:

  • 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 NYHA Class III or IV congestive heart failure or LVEF <50% or history of significant cardiac disease, unstable angina, congestive heart failure, myocardial infarction, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04100694

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Contact: For Information + 31 88 525 3 888

Sponsors and Collaborators
Merus N.V.
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Responsible Party: Merus N.V. Identifier: NCT04100694    
Other Study ID Numbers: MCLA-128-CL99; MCLA-128-CL98
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Keywords provided by Merus N.V.:
Early Access
Pancreas cancer
Non Small Cell Lung Cancer
Solid tumor
Compassionate use
Expanded access
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Neoplasms, Unknown Primary
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Urogenital Neoplasms
Urogenital Diseases
Male Urogenital Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Kidney Diseases
Urologic Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes