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

2019-09-27 06:30:42 | BioPortfolio


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.

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Merus N.V.

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Published on BioPortfolio: 2019-09-27T06:30:42-0400

Clinical Trials [6 Associated Clinical Trials listed on BioPortfolio]

A Study of MCLA-128 in Patients With Solid Tumors

This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single group assignment study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor act...

A Phase 1, Multinational Study of MCLA-117 in Acute Myelogenous Leukemia

This is a First-in-Human, single arm, open-label, multi-national study designed to determine the safety, tolerability and preliminary efficacy of MCLA 117.

A Study of Bispecific Antibody MCLA-145 in Patients With Advanced Solid Tumors

This is a Phase 1, open label, non-randomised, dose-escalation single agent study with expansion cohorts for dose confirmation/safety and preliminary efficacy of MCLA-145 in selected advan...

A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors

This is a Phase I, open-label, multi-center, multi-national, dose escalation, single agent study to determine the recommended Phase II dose (RP2D) of MCLA-158 in metastatic colorectal canc...

MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer

A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Coh...

PubMed Articles [12 Associated PubMed Articles listed on BioPortfolio]

Therapeutic efficacy of neuregulin 1-expressing human adipose-derived mesenchymal stem cells for ischemic stroke.

Adipose-derived mesenchymal stem cells (AdMSCs) have been reported to ameliorate neurological deficits after acute ischemic stroke. As neuregulin 1 (NRG1, or heregulin 1), a growth factor with versati...

Association of Neuregulin 1 rs7835688 G > C, rs16879552 T > C and rs2439302 G > C Polymorphisms with Susceptibility to Non-Syndromic Hirschsprung's Disease.

Hirschsprung's disease (HSCR) is a heterogeneous congenital malformation of the enteric nervous system with a complex genetic etiology. We investigated if there was an association between Neuregulin-1...

Impaired social discrimination behavior despite normal social approach by kallikrein-related peptidase 8 knockout mouse.

For social mammals, recognition of conspecifics and discrimination of each other (social memory) is crucial to living in a stable colony. Here, we investigated whether kallikrein-related peptidase 8 (...

Behavioural effects of high fat diet in adult Nrg1 type III transgenic mice.

Some diets appear to have detrimental effects on schizophrenia symptoms. Neuregulin 1 (NRG1) is a risk gene for schizophrenia and a recently developed transgenic mouse model for Nrg1 type III demonstr...

Neuregulin and ErbB expression is regulated by development and sensory experience in mouse visual cortex.

Neuregulins (NRGs) are protein ligands that impact neural development and circuit function. NRGs signal through the ErbB receptor tyrosine kinase family. NRG1/ErbB4 signaling in parvalbumin-expressing...

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An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...

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