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
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
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- Ability to give written, informed consent prior to treatment, with the understanding that the consent may be withdrawn by the patient at any time without prejudice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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
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Primary Completion Date
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Study Completion Date
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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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