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

NCT07491497 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-07

No results posted yet for this 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

Conditions

  • ALK-positive NSCLC
  • ALK-Positive Lung Cancer
  • ALK-positive Non-small Cell Lung Cancer

Interventions

DRUG

TRI-611

oral ALK molecular glue degrader

Sponsors & Collaborators

  • TRIANA Biomedicines, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-11
Primary Completion
2029-05-31
Completion
2034-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07491497 on ClinicalTrials.gov