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Phase 1/2 Study of TRI-611 for ALK-Positive Lung Cancer

This study is testing a new oral drug called TRI-611 for adults with ALK-positive non-small cell lung cancer (NSCLC). TRI-611 works by targeting the ALK protein. To join, you must have ALK-positive NSCLC that has been confirmed by a doctor and measurable disease. You also need to have good bone marrow and organ function. For some parts of the study, you must have had previous treatments with ALK TKIs (tyrosine kinase inhibitors), including lorlatinib. The study aims to find a safe dose of TRI-611 and see how well it works to shrink tumors. The study plans to enroll 160 participants, but its current status is unclear.

Study design
This is a Phase 1/2 study that will first determine the best dose of TRI-611, then expand to look at its effectiveness in different groups of participants. It will involve 160 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the drug works approximately 16 weeks after the last participant receives their dose in Part 2.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07491497

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
TRIANA Biomedicines, Inc.
~160 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:TRI-611

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Treatment emergent adverse events
Measured over Within 28 days of the first TRI-611 dose
+2 more outcomes measured

Conditions

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

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

12 sites across 11 states
Massachusetts2
California1
Colorado1
Missouri1
New York1
North Carolina1
Ohio1
Tennessee1

Who to contact

TRIANA Clinical Trials
[email protected]
Email the study team

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Eligibility criteria

Inclusion

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 is required but must not have been in the first line
Part 2 Cohort M1: prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line, prior treatment with neladalkib is excluded
Part 2 Cohort M2: prior treatment with more than 3 ALK TKIs, prior treatment with lorlatinib and neladalkib is required but neither may have been in the first line
Part 2 Cohort M3: participants without prior ALK TKI treatment

Exclusion

Participant's cancer has any additional driver alterations known to be a mechanism of resistance to ALK TKIs
For participants with central nervous system (CNS) metastases or spinal cord compression, they must not be associated with progressive neurological symptoms or require 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

What this trial measures

  • Part 1: Treatment emergent adverse eventsWithin 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