RecruitingPhase 1Phase 2NCT07491497

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

A Phase 1/2, Dose Escalation and Expansion Study of TRI-611, an Oral ALK Molecular Glue Degrader in Participants With Advanced ALK-Positive NSCLC


Sponsor

TRIANA Biomedicines, Inc.

Enrollment

160 participants

Start Date

Mar 11, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called TRI-611 for people with alk-positive lung cancer, alk-positive nsclc, and other related conditions. The study is currently recruiting participants at 11 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTRI-611

oral ALK molecular glue degrader


Locations(16)

UCSF

San Francisco, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Center

Boston, Massachusetts, United States

Washington University Medical Center

St Louis, Missouri, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Duke University

Durham, North Carolina, United States

University of Cincinnati Cancer Center

Cincinnati, Ohio, United States

Taylor Cancer Research Center

Maumee, Ohio, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Oncology Consultants Research (P1 Trials)

Houston, Texas, United States

START-Mountain Region

West Valley City, Utah, United States

NEXT Virginia

Fairfax, Virginia, United States

Royal North Shore Hospital

Sydney, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07491497


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