A Phase 1/2 Open-Label Multi-Center First-in-Human Study of the Safety Tolerability Pharmacokinetics and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK ROS1 or NTRK1-3 Rearrangements (TRIDENT-1)

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A Phase 1/2 Open-Label Multi-Center First-in-Human Study of the Safety Tolerability Pharmacokinetics and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK ROS1 or NTRK1-3 Rearrangements (TRIDENT-1)

Brief description of study

Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. (*site is not participating in the sub-study) Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Clinical Study Identifier: s19-00440

ClinicalTrials.gov Identifier: NCT03093116

Principal Investigator: Salman Rafi Punekar.

Other Investigators: Samantha VanMaanen, Jessica Wang, Elaine Shum, Carol M Lee, Jonathan B Kahn, Gabrielle Fridman, Joshua K Sabari, David Mendoza, Melissa L Martinez, Natalia Cherkassky.

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Perlmutter Cancer Center

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