Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors

Phase 2 Recruiting 52 enrolled St. Jude Children's Research Hospital Hoffmann-La Roche · collab

NaSingle-groupOpen-labelTreatment

Summary

This clinical trial tests how well entrectinib works to treat patients less than 3 years of age with NTRK 1/2/3 or ROS1 fused, high grade glioma or other central nervous system (CNS) tumors.

Timeline

Start: 2026-05-01
Primary completion: 2027-11
Completion: 2032-11

Publications

Bagchi A, Chiang J, Pinto S, Dhanda S, Gajjar A. Infant-Type Hemispheric Gliomas: A Review of Clinical, Radiologic, Histopathologic, and Molecular Features. J Natl Compr Canc Netw. 2025 Nov;23(11):e257064. doi: 10.6004/jnccn.2025.7064.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Entrectinib	Small molecule	—	Oral
Background	Carboplatin	Small molecule	—	Intravenous
Background	Cyclophosphamide	Other / unclassified	—	Intravenous
Background	Etoposide	Small molecule	—	Intravenous
Background	Pegfilgrastim	Protein / enzyme biologic	—	Subcutaneous
Background	filgrastim	Protein / enzyme biologic	—	Subcutaneous

Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors

Summary

Timeline

Publications

Drugs

Indications