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

Last updated: May 6, 2026
Sponsor: TRIANA Biomedicines, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

TRI-611

Clinical Study ID

NCT07491497
TRI-611-101
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Pathologically confirmed diagnosis of ALK-positive non-small cell lung cancer (NSCLC)

  • Measurable disease per RECIST v1.1

  • Adequate bone marrow reserve and organ function

  • Part 1: prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib isrequired but must not have been in the first line

  • Part 2 Cohort M1: prior treatment with 2 to 3 ALK TKIs, prior treatment withlorlatinib is required but must not have been in the first line, prior treatmentwith neladalkib is excluded

  • Part 2 Cohort M2: prior treatment with more than 3 ALK TKIs, prior treatment withlorlatinib and neladalkib is required but neither may have been in the first line

  • Part 2 Cohort M3: participants without prior ALK TKI treatment

Exclusion

Exclusion Criteria:

  • Participant's cancer has any additional driver alterations known to be a mechanismof resistance to ALK TKIs

  • For participants with central nervous system (CNS) metastases or spinal cordcompression, they must not be associated with progressive neurological symptoms orrequire increasing doses of corticosteroids to control the CNS disease

  • Ongoing treatment with another anticancer treatment or investigational agent

  • Known allergy/hypersensitivity to TRI-611 or any of its ingredients

  • Major surgery within 4 weeks of receiving the first dose of TRI-611

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: TRI-611
Phase: 1/2
Study Start date:
March 11, 2026
Estimated Completion Date:
January 30, 2034

Study Description

This is a Phase 1/2 dose escalation and dose expansion study designed to evaluate the safety and tolerability of TRI-611, identify the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in participants with ALK-positive NSCLC.

Part 1 of the study consists of a dose escalation to determine the MTD and/or recommended dose(s) of TRI-611 for further exploration in two backfill cohorts.

Following completion of Part 1 of the study, Part 2 of the study will be initiated. The second part of the study is comprised of three cohorts (M1, M2, M3) of participants differentiated based on their previous treatment with ALK TKIs (tyrosine kinase inhibitors). During this part of the study the antitumor activity of TRI-611 will be further explored. See eligibility criteria for more details.

Connect with a study center

  • University of Colorado Cancer Center

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Washington University Medical Center

    St Louis, Missouri 63130
    United States

    Active - Recruiting

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Taylor Cancer Research Center

    Maumee, Ohio 43537
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • START Mountain Region

    West Valley City, Utah 84119
    United States

    Active - Recruiting

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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