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ALK-positive NSCLCPhase 1/2NCT07491497

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

A Phase 1/2 study testing TRI-611 in people with ALK-positive NSCLC and ALK-Positive Lung Cancer, run by TRIANA Biomedicines, Inc. at 20 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TRI-611
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
20 sitesin 4 countries
Study dates
11 Mar 2026to 30 Jan 2034
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 [in US only: '2 or more 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

Who cannot join

  • 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

Trial locations and contacts

20 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

TRIANA Clinical Trials contact

medical@trianabio.com

20 sites in 4 countries

United States14 sites, 14 recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

    Emily Adam, 303-724-8843, emily.adam@cuanschutz.edu

    Kyle Concannon, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Jessica Lin, MD, 617-724-4000, jjlin1@mgb.org

    Jessica Lin, MD

    Recruiting

  • Dana Farber Cancer Center

    Boston, Massachusetts, 02215

    Alice Shaw, MD, 877-442-3324, dfcitopreferrals@dfci.harvard.edu

    Alice Shaw, MD

    Recruiting

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45221

    Jennifer Leddon, MD

    Recruiting

  • Duke University

    Durham, North Carolina, 27710-2000

    Thomas Stinchcombe, MD

    Recruiting

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Alexander Spira, MD

    Recruiting

  • Oncology Consultants Research (P1 Trials)

    Houston, Texas, 77030

    Julio Peguero, MD, 713-600-0071, jpeguero@oncologyconsultants.com

    Julio Peguero, MD

    Recruiting

  • Taylor Cancer Research Center

    Maumee, Ohio, 43537

    Stephanie Ambrose, 567-402-4500, sambrose@tcrcpt.org

    John Nemunaitis, MD

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    AskSarah, 844-482-4814, scri.ddureferrals@scri.com

    Melissa Johnson, MD

    Recruiting

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

    Memorial Sloan Kettering Cancer Center, 646-608-3758

    Alexander Drilon, MD

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15213

    Lisa Villaruz, MD

    Recruiting

  • UCSF

    San Francisco, California, 94158

    Collin Blakely, MD

    Recruiting

  • Washington University Medical Center

    St Louis, Missouri, 63130

    Gina Vellequette, 314-362-0872, g.vellequette@wustl.edu

    Saiama Waqar, MD

    Recruiting

  • START-Mountain Region

    West Valley City, Utah, 84119

    HOPE Team, 801-907-4750, hopeteam@startresearch.com

    José Pacheco, MD

    Recruiting

Other trials in United States

Australia3 sites, 3 recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

    Ben Solomon, MD

    Recruiting

  • Royal North Shore Hospital

    Sydney, New South Wales, 2000

    Malinda Itchins, MD

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Adnan Nagrial, MD

    Recruiting

Other trials in Australia

France2 sites, 2 recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Aurelie Swalduz, MD

    Recruiting

  • Gustave Roussy Institute

    Villejuif, 94800

    Anas Gazzah, MD

    Recruiting

Other trials in France

United Kingdom1 site, 1 recruiting

  • The Royal Marsden NHS Foundation

    Sutton, SM2 5PT

    Anna Minchom, MD

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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.

Read more

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
Read the 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.

Being tested
TRI-611

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRI-611Drug

    oral ALK molecular glue degrader

Study groups in NCT07491497
Study groupRoleWhat they receive
Part 1: Dose Escalation and BackfillExperimentalPrior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line
Receives: Drug: TRI-611
Part 2: Cohort M1ExperimentalPrior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is excluded
Receives: Drug: TRI-611
Part 2: Cohort M2ExperimentalPrior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is required
Receives: Drug: TRI-611
Part 2: Cohort M3ExperimentalParticipants without prior ALK TKI treatment
Receives: Drug: TRI-611

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Treatment emergent adverse events

    Treatment emergent adverse events (TEAEs)

    Measured: Within 28 days of the first TRI-611 dose

  2. Part 2: Objective response rate (ORR)

    Determine the objective response rate (ORR) based on RECIST v1.1

    Measured: Approximately 16 weeks after the last participant dosed in Part 2

  3. Part 2: Depth of response (DofR)

    Defined as the greatest percentage reduction in the sum of diameters of target lesions from baseline

    Measured: Approximately 16 weeks after the last participant dosed in Part 2

Secondary outcomes (15)

  1. Part 1: Half-life (t1/2) of TRI-611

    Determine the t1/2 of TRI-611

    Measured: Pre-dose and up to 24 hours post-dose

  2. Part 1: Area under the curve (AUC) of TRI-611

    Determine the AUC of TRI-611

    Measured: Pre-dose and up to 24 hours post-dose

  3. Part 1: Maximum plasma concentration (Cmax) of TRI-611

    Determine the Cmax of TRI-611

    Measured: Pre-dose and up to 24 hours post-dose

  4. Part 1: Minimum plasma concentration (Cmin) of TRI-611

    Determine the Cmin of TRI-611

    Measured: Pre-dose and up to 24 hours post-dose

  5. Part 1: ORR

    Determine the ORR based on RECIST v1.1

    Measured: Approximately 16 weeks after the last participant dosed in Part 1

  6. Part 1: DofR

    Defined as the greatest percentage reduction in the sum of diameters of target lesions from baseline

    Measured: Approximately 16 weeks after the last participant dosed in Part 1

  7. Parts 1&2: Duration of response (DOR)

    Determine the DOR based on RECIST v1.1

    Measured: Approximately 5 years after the last participant is dosed with TRI-611

  8. Parts 1&2: Disease control rate (DCR)

    Defined as the number and percentage of participants who have achieved a response or stable disease based on RECIST v1.1

    Measured: Approximately 16 weeks after the last participant dosed

  9. Parts 1&2: Clinical Benefit Rate (CBR)

    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

    Measured: Approximately 9 months after the last participant is dosed

  10. Parts 1&2: Progression-free survival (PFS)

    Determine PFS based on RECIST v1.1

    Measured: Approximately 5 years after the last participant is dosed with TRI-611

  11. Parts 1&2: Overall survival (OS)

    Determine OS based on RECIST v1.1

    Measured: Approximately 5 years after the last participant is dosed with TRI-611

  12. Parts 1&2: Central Nervous System (CNS) objective response rate (ORR)

    Determine CNS ORR based on modified RECIST (mRECIST v1.1) in participants with CNS metastasis at baseline

    Measured: Approximately 16 weeks after the last participant dosed

  13. Parts 1&2: CNS duration of response (DOR)

    Determine CNS DOR based on mRECIST v1.1 in participants with CNS metastasis at baseline

    Measured: Approximately 5 years after the last participant is dosed with TRI-611

  14. Parts 1&2: Time to intracranial progression (TTP)

    Defined as the time to the date of the first documentation of objective progression of intracranial disease

    Measured: Approximately 5 years after the last participant is dosed with TRI-611

  15. Part 1: Profile changes in tumor ALK-fusion protein levels

    Assessing treatment-induced modulation of ALK expression only in participants consenting to on-treatment biopsies

    Measured: Approximately 14 days after the last dose of participants in Part 1 that have consented to on-treatment biopsies

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2026
  2. Study start11 Mar 2026
  3. Primary completion31 May 2029 (estimated)
  4. Study completion30 Jan 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Part 1 of the study consists of approximately 5 dose escalation cohorts and 2 backfill cohorts. Part 2 of the study consists of 3 cohorts of participants differentiated based on their previous treatment with ALK TKIs.
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07491497
Sponsor's protocol ID
TRI-611-101
Status last verified
Nov 2026
First submitted
11 Mar 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TRI-611 in people with ALK-positive NSCLC and ALK-Positive Lung Cancer, run by TRIANA Biomedicines, Inc. at 20 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Australia, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact TRIANA Clinical Trials (medical@trianabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Treatment emergent adverse events (time frame: Within 28 days of the first TRI-611 dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07491497.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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