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

Condition(s) studied

Investigational drug(s) / intervention(s)

TRI-611: oral ALK molecular glue degrader

Study summary

The goal of this clinical trial is to learn about the safety and recommended dose of TRI-611 when administered to adults with ALK-positive non-small cell lung cancer (NSCLC). The trial will also evaluate the antitumor activity of TRI-611 in adults with ALK-positive NSCLC.

The study will be conducted in two parts. The first part will examine different doses of TRI-611. The second part will look at how well TRI-611 works on ALK-positive NSCLC when administered to three groups of participants that differ based on what type of prior therapy they have received.

In this study participants will:

* Take TRI-611 on a continued basis, provided it is well-tolerated, for as long as their disease is not progressing
* Visit the clinic approximately seven times in the first 3 months and then just once at the start of each 28-day cycle thereafter
* Keep a diary of each time they take the study medication

Eligibility

Primary outcome measure(s)

• Part 1: Treatment emergent adverse events — Within 28 days of the first TRI-611 dose
  Treatment emergent adverse events (TEAEs)
• Part 2: Objective response rate (ORR) — Approximately 16 weeks after the last participant dosed in Part 2
  Determine the objective response rate (ORR) based on RECIST v1.1
• Part 2: Depth of response (DofR) — Approximately 16 weeks after the last participant dosed in Part 2
  Defined as the greatest percentage reduction in the sum of diameters of target lesions from baseline

Trial sites (16)