Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor
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ClinicalTrials.gov Identifier: NCT04100694 |
Expanded Access Status :
Available
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
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Sponsor:
Merus N.V.
Information provided by (Responsible Party):
Merus N.V.
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Tracking Information | |||||||||
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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 |
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Intervention | Drug: MCLA-128 | ||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Expanded Access Status | Available | ||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Contacts |
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Listed Location Countries | Not Provided | ||||||||
Removed Location Countries | |||||||||
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 |