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

Primary Purpose

NRG1, NRG1 Fusion, Pancreatic Cancer

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
MCLA-128
Sponsored by
Merus N.V.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for NRG1 focused on measuring Early Access, NRG1, Pancreas cancer, Non Small Cell Lung Cancer, Solid tumor, Compassionate use, Expanded access

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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  • Ability to give written, informed consent prior to treatment, with the understanding that the consent may be withdrawn by the patient at any time without prejudice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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 20, 2019
    Last Updated
    July 21, 2021
    Sponsor
    Merus N.V.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04100694
    Brief Title
    Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor
    Official Title
    Treatment Plan of the HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merus N.V.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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
    Keywords
    Early Access, NRG1, Pancreas cancer, Non Small Cell Lung Cancer, Solid tumor, Compassionate use, Expanded access

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MCLA-128

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    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: 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 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    For Information
    Phone
    + 31 88 525 3 888
    Email
    merus@mytomorrows.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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