The TRIDENT-1 trial is a Phase 1/2 open-label, multicenter study evaluating repotrectinib (TPX-0005), an oral macrocyclic tyrosine kinase inhibitor, in adults with advanced solid tumors harboring documented ALK, ROS1 or NTRK1-3 gene rearrangements. The primary objective is to determine safety, tolerability, the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and to assess confirmed objective response rate (cORR) by a blinded independent central review (BICR). Eligible participants are adults with measurable disease, performance status (ECOG) 0–1, and confirmed gene rearrangement status via testing at screening. Treatment is administered orally in dose-escalation cohorts followed by expansion cohorts. Key secondary endpoints include duration of response (DOR), progression-free survival (PFS), overall survival (OS) and pharmacokinetics.
This study investigates the investigational drug repotrectinib (TPX-0005) in adults with advanced solid tumors harboring ALK, ROS1 or NTRK1-3 gene rearrangements. The aim is to evaluate safety and explore early signs of anti-tumor activity. Eligible participants are adults with confirmed molecular gene alterations and advanced disease with adequate performance status. The treatment is given orally in a dose-escalation phase followed by an expansion cohort. Additional key objectives include tolerability, pharmacokinetics and duration of response.
