Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors

Inclusion Criteria: To be eligible for participation in the study, patients must meet the following inclusion criteria: * Locally-advanced or metastatic solid tumor with an NRG1 gene fusion identified through molecular assays, such as PCR, NGS (RNA or DNA) or FISH, by a CLIA-certified or similarly accredited laboratory * Availability of fresh or archived FFPE tumor sample to be submitted to a central laboratory for confirmation of NRG1 gene fusion status * Patients should have received a minimum of one prior standard therapy appropriate for their tumor type and stage of disease, progressed or been nonresponsive to these available therapies, with no further available curative therapy options * ≥ 18 years of age * ECOG performance status (PS) 0, 1 or 2 * Patients must have at least one measurable extra-cranial lesion as defined by RECIST v1.1 * Adequate hepatic function defined as: * Serum AST and serum ALT \< 2.5 × upper limit of normal (ULN), or AST and ALT \< 5 × ULN if liver function abnormalities due to underlying malignancy * Total bilirubin \< 2.0 ULN. Subjects with a known history of Gilberts Disease and an isolated elevation of indirect bilirubin are eligible * Adequate hematologic status, defined as: * Absolute neutrophil count (ANC) ≥1.5 × 109/L not requiring growth factor support for at least 7 days prior to Screening, and * Platelet count ≥100.0×109/L not requiring transfusion support for at least 7 days prior to Screening * Able to provide informed consent or ha…