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

May 6, 2026 updated by: TRIANA Biomedicines, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University Of Colorado Cancer Center
        • Principal Investigator:
          • Kyle Concannon, MD
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Recruiting
        • Washington University Medical Center
        • Principal Investigator:
          • Saiama Waqar, MD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan-Kettering Cancer Center
        • Principal Investigator:
          • Alexander Drilon, MD
        • Contact:
          • Memorial Sloan Kettering Cancer Center
          • Phone Number: 646-608-3758
    • Ohio
      • Maumee, Ohio, United States, 43537
        • Recruiting
        • Taylor Cancer Research Center
        • Principal Investigator:
          • John Nemunaitis, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
        • Principal Investigator:
          • Melissa Johnson, MD
        • Contact:
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • START Mountain Region
        • Principal Investigator:
          • José Pacheco, MD
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Next Virginia
        • Principal Investigator:
          • Alexander Spira, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Dose Escalation and Backfill
Prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line
Drug: TRI-611
oral ALK molecular glue degrader
Experimental: Part 2: Cohort M1
Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is excluded
Drug: TRI-611
oral ALK molecular glue degrader
Experimental: Part 2: Cohort M2
Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is required
Drug: TRI-611
oral ALK molecular glue degrader
Experimental: Part 2: Cohort M3
Participants without prior ALK TKI treatment
Drug: TRI-611
oral ALK molecular glue degrader

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Treatment emergent adverse events
Time Frame: Within 28 days of the first TRI-611 dose
Treatment emergent adverse events (TEAEs)
Within 28 days of the first TRI-611 dose
Part 2: Objective response rate (ORR)
Time Frame: Approximately 16 weeks after the last participant dosed in Part 2
Determine the objective response rate (ORR) based on RECIST v1.1
Approximately 16 weeks after the last participant dosed in Part 2
Part 2: Depth of response (DofR)
Time Frame: 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
Approximately 16 weeks after the last participant dosed in Part 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Half-life (t1/2) of TRI-611
Time Frame: Pre-dose and up to 24 hours post-dose
Determine the t1/2 of TRI-611
Pre-dose and up to 24 hours post-dose
Part 1: Area under the curve (AUC) of TRI-611
Time Frame: Pre-dose and up to 24 hours post-dose
Determine the AUC of TRI-611
Pre-dose and up to 24 hours post-dose
Part 1: Maximum plasma concentration (Cmax) of TRI-611
Time Frame: Pre-dose and up to 24 hours post-dose
Determine the Cmax of TRI-611
Pre-dose and up to 24 hours post-dose
Part 1: Minimum plasma concentration (Cmin) of TRI-611
Time Frame: Pre-dose and up to 24 hours post-dose
Determine the Cmin of TRI-611
Pre-dose and up to 24 hours post-dose
Part 1: ORR
Time Frame: Approximately 16 weeks after the last participant dosed in Part 1
Determine the ORR based on RECIST v1.1
Approximately 16 weeks after the last participant dosed in Part 1
Part 1: DofR
Time Frame: Approximately 16 weeks after the last participant dosed in Part 1
Defined as the greatest percentage reduction in the sum of diameters of target lesions from baseline
Approximately 16 weeks after the last participant dosed in Part 1
Parts 1&2: Duration of response (DOR)
Time Frame: Approximately 5 years after the last participant is dosed with TRI-611
Determine the DOR based on RECIST v1.1
Approximately 5 years after the last participant is dosed with TRI-611
Parts 1&2: Disease control rate (DCR)
Time Frame: Approximately 16 weeks after the last participant dosed
Defined as the number and percentage of participants who have achieved a response or stable disease based on RECIST v1.1
Approximately 16 weeks after the last participant dosed
Parts 1&2: Clinical Benefit Rate (CBR)
Time Frame: Approximately 9 months after the last participant is dosed
Defined as the number and percentage of participants who have achieved a response or stable disease based on RECIST v1.1 maintained for a minimum of 6 months
Approximately 9 months after the last participant is dosed
Parts 1&2: Progression-free survival (PFS)
Time Frame: Approximately 5 years after the last participant is dosed with TRI-611
Determine PFS based on RECIST v1.1
Approximately 5 years after the last participant is dosed with TRI-611
Parts 1&2: Overall survival (OS)
Time Frame: Approximately 5 years after the last participant is dosed with TRI-611
Determine OS based on RECIST v1.1
Approximately 5 years after the last participant is dosed with TRI-611
Parts 1&2: Central Nervous System (CNS) objective response rate (ORR)
Time Frame: Approximately 16 weeks after the last participant dosed
Determine CNS ORR based on modified RECIST (mRECIST v1.1) in participants with CNS metastasis at baseline
Approximately 16 weeks after the last participant dosed
Parts 1&2: CNS duration of response (DOR)
Time Frame: Approximately 5 years after the last participant is dosed with TRI-611
Determine CNS DOR based on mRECIST v1.1 in participants with CNS metastasis at baseline
Approximately 5 years after the last participant is dosed with TRI-611
Parts 1&2: Time to intracranial progression (TTP)
Time Frame: Approximately 5 years after the last participant is dosed with TRI-611
Defined as the time to the date of the first documentation of objective progression of intracranial disease
Approximately 5 years after the last participant is dosed with TRI-611
Part 1: Profile changes in tumor ALK-fusion protein levels
Time Frame: Approximately 14 days after the last dose of participants in Part 1 that have consented to on-treatment biopsies
Assessing treatment-induced modulation of ALK expression only in participants consenting to on-treatment biopsies
Approximately 14 days after the last dose of participants in Part 1 that have consented to on-treatment biopsies

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TRIANA Biomedicines, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2026

Primary Completion (Estimated)

May 31, 2029

Study Completion (Estimated)

January 30, 2034

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • TRI-611-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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