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

• ClinicalTrials.gov Identifier: NCT04100694
• Expanded Access Status: Available
• First Posted: September 24, 2019
• Last Update Posted: September 24, 2019
• Sponsor: Merus N.V.
• Information provided by (Responsible Party): Merus N.V.

Tracking Information

• First Submitted Date: September 20, 2019
• First Posted Date: September 24, 2019
• Last Update Posted Date: September 24, 2019

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Expanded Access
• Expanded Access Type: Individual Patients

Condition

• NRG1
• NRG1 Fusion
• Pancreatic Cancer
• Non Small Cell Lung Cancer
• Solid Tumor, Unspecified, Adult

• Intervention: Drug: MCLA-128
• Publications *: Not Provided

Recruitment Information

• Expanded Access Status: Available

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:

  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 3
• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)

Contacts

Contact: Michel Van Harten, MD; + 31 88 525 3 888; michel.vanharten@mytomorrows.com

Contact: Karlijn Doorn, PhD; + 31 88 525 3 888; karlijn.doorn@mytomorrows.com

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04100694
• Other Study ID Numbers: MCLA-128-CL99
• Responsible Party: Merus N.V.
• Study Sponsor: Merus N.V.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Merus N.V.
• Verification Date: September 2019