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Association details:
| Biomarker: | NRG1 fusion |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | zenocutuzumab (MCLA-128) (HER2 inhibitor, HER3 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Merus Granted FDA Fast Track Designation of Zenocutuzumab for the Treatment of Patients with Neuregulin 1 Fusion Cancers
Published date:
01/07/2021
Excerpt:
Merus N.V...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Zenocutuzumab (Zeno) for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancers) that have progressed on standard of care therapy...
Source:
Title:
Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor
Excerpt:
...- 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....
Trial ID:
Source:
Title:
A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)
Excerpt:
...- Locally-advanced unresectable or metastatic solid tumor malignancy with documented NRG1 gene fusion, identified through molecular assays such as next generation sequencing-based assays [DNA or RNA], as routinely performed at CLIA or other similarly-certified laboratories....
Trial ID:
More C2 evidence
Source:
Title:
Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers
Excerpt:
...Have histologically confirmed locally advanced, unresectable, or metastatic NSCLC harboring an NRG1 gene fusion detected by DNA- or RNA-based next generation sequencing in a tumor sample or in plasma-cell free DNA....
Trial ID:
