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

Phase 2 Terminated 54 enrolled Elevation Oncology

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is an open-label, international, multi-center, Phase 2 study in adult patients with recurrent, locally-advanced or metastatic solid tumors, which harbor the NRG1 gene fusion.

Timeline

Start: 2020-09-29
Primary completion: 2024-02-28
Completion: 2024-02-28

Publications

Patil T, Lin JJ, Cheema PK, Carrizosa DR, Burkard ME, Elamin YY, Desai J, Patel JD, Nagasaka M, Reckamp KL, Waqar SN, Bauman JR, Schram AM, Gadgeel SM, Ma PC, Konduri K, Nguyen D, Misleh J, Bleeker J, Weiss M, Thavaneswaran S, Haura EB, Deegan M, Kaufman J, Srivastava J, Jansen VM, Liu SV. CRESTONE: A Phase II Study of the Efficacy and Safety of the HER3 Monoclonal Antibody, Seribantumab, in Solid Tumors With Neuregulin-1 (NRG1) Fusions. JCO Precis Oncol. 2025 Aug;9:e2500221. doi: 10.1200/PO-25-00221. Epub 2025 Dec 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Seribantumab	Monoclonal antibody	3000 mg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications