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NCT Number: NCT07491497

A Phase 1/2 Study of TRI-611 in 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

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UCSF, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRI-611

Drug

oral ALK molecular glue degrader

Primary outcomes

  1. Part 1: Treatment emergent adverse events

    Time frame: Within 28 days of the first TRI-611 dose

    Treatment emergent adverse events (TEAEs)

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Part 1: ORR

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

    Determine the ORR based on RECIST v1.1

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

Study contacts

Contact information is provided by the study sponsor or research team.

TRIANA Clinical Trials

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

TRIANA Biomedicines, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2034
First posted
Mar 24, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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