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

NCT07491497 | Recruiting Phase 1 FDA Drug

• 1 other identifier: TRI-611-101
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Part 1: Treatment emergent adverse events

  Treatment emergent adverse events (TEAEs)

  Within 28 days of the first TRI-611 dose

• Part 2: Objective response rate (ORR)

  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)

  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 Outcomes (15)

• Part 1: Half-life (t1/2) of TRI-611

  Pre-dose and up to 24 hours post-dose

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

  Pre-dose and up to 24 hours post-dose

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

  Pre-dose and up to 24 hours post-dose

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

  Pre-dose and up to 24 hours post-dose

• Part 1: ORR

  Approximately 16 weeks after the last participant dosed in Part 1

Study Arms (4)

Part 1: Dose Escalation and Backfill

EXPERIMENTAL

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

Part 2: Cohort M1

EXPERIMENTAL

Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is excluded

Drug: TRI-611

Part 2: Cohort M2

EXPERIMENTAL

Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is required

Drug: TRI-611

Part 2: Cohort M3

EXPERIMENTAL

Participants without prior ALK TKI treatment

Drug: TRI-611

Interventions

TRI-611 DRUG

oral ALK molecular glue degrader

Part 1: Dose Escalation and Backfill; Part 2: Cohort M1; Part 2: Cohort M2; Part 2: Cohort M3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TRIANA Biomedicines, Inc.: lead

Study Sites (7)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

RECRUITING

Washington University Medical Center

St Louis, Missouri, 63130, United States

RECRUITING

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Taylor Cancer Research Center

Maumee, Ohio, 43537, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Central Study Contacts

TRIANA Clinical Trials

CONTACT

medical@trianabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 24, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): January 30, 2034
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

US (7)