Evaluating Safety, Dose, and Effectiveness of Oral TRI-611 in Adults with Advanced ALK-Positive Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are studying TRI-611, an oral ALK molecular glue degrader, in adults with ALK-positive non-small cell lung cancer NSCLC. This Phase 12 trial aims to determine the safety, tolerability, and recommended dose of TRI-611 while also evaluating its antitumor activity. The study is sponsored by TRIANA Biomedicines, Inc. and focuses on participants who have varying prior treatments with ALK tyrosine kinase inhibitors TKIs. The trial has two parts Part 1 involves dose escalation to find the maximum tolerated dose and recommended Phase 2 dose through backfill cohorts. Part 2 includes three cohorts based on participants previous ALK TKI treatments, exploring the antitumor activity of TRI-611. Participants will take TRI-611 continuously while their disease does not progress. They will visit the clinic about seven times during the first three months and then once at the start of each 28-day cycle thereafter. Participants will keep a diary to record each dose of the study medication. Safety and response will be monitored through assessments such as adverse events within 28 days of the first dose and objective response rates approximately 16 weeks after dosing. The study also measures tumor response depth, duration of response, progression-free survival, and overall survival for up to five years after dosing. This includes special assessments for central nervous system involvement and tumor protein levels in consenting participants.

A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC