Trial Identifiers
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Scientific Title
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
Commercial Sponsor
Turning Point Therapeutics, Inc.
Summary
This is a dose escalation (Phase I) and expansion (Phase II) trial. In Phase I, eligible participants will receive escalating doses of Oral repotrectinib, to determine the first cycle dose-limiting toxicities, maximum tolerated dose, biologically effective dose and recommended phase 2 dose. In Phase II, participants will receive Oral repotrectinib across six distinct expansion cohorts, depending on their prior treatment and disease progression.