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

NCT#: & Link

NCT04094610

NCT QR Code

Available as of:

September 3, 2024

Contract:

Caris

Indication Category:

Solid Tumors

Study Sponsor:

Turning Point Therapeutics, Inc

Protocol #:

TPX-0005-07

Title:

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

Highlight Details:

A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and
Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations

Biomarkers:

NTRK FUSIONS

Indication:

Solid Tumors

Phase:

2

Treatment Line:

Study Drug/Test Compound:

TPX-0005/Repotrectinib

Notes

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).
Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.

Recruitment Status:

Just In Time

Participating Institution:

Salinas Valley Health

Salinas Valley Health Clinical Research Program:

Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, [email protected]