A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

2019-09-24 05:27:32 | BioPortfolio


Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D).


Enrollment of subjects into Phase 1 will proceed concurrently by age as follows:

• Subjects 4 to <12 years old will initially be enrolled in the Phase 1 part to determine the pediatric RP2D for this age group.

Phase 1:

Approximately 12 pediatric subjects with locally advanced or metastatic solid tumors, including a primary central nervous system (CNS) tumor, or anaplastic large cell lymphoma (ALCL), with disease progression or who are non-responsive or intolerant to available therapies and for which no standard or available curative therapy exists.

Study Design


Locally Advanced Solid Tumors


Oral repotrectinib (TPX-0005)


Not yet recruiting


Turning Point Therapeutics, Inc.

Results (where available)

View Results


Published on BioPortfolio: 2019-09-24T05:27:32-0400

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