Recruiting

Phase 1

Phase 2

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

Sponsor:

TRIANA Biomedicines, Inc.

Code:

NCT07491497

Conditions

ALK-positive NSCLC

ALK-Positive Lung Cancer

ALK-positive Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TRI-611

Study Details

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 NSCLC

ALK-Positive Lung Cancer

ALK-positive Non-small Cell Lung Cancer

Study ID

NCT07491497

Start date

Mar 11, 2026

Status verified date

Sep, 2026

Completion date

Jan 30, 2034

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 \[in US only: '2 or more ALK TKIs'\], 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

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 Design

Enrollment

160 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

experimental: Part 2: Cohort M1

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

experimental: Part 2: Cohort M2

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

experimental: Part 2: Cohort M3

Participants without prior ALK TKI treatment

Interventions

TRI-611

oral ALK molecular glue degrader

Primary outcome measure

Part 1: Treatment emergent adverse events [ Time Frame: 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 ]
Part 2: Depth of response (DofR) [ Time Frame: Approximately 16 weeks after the last participant dosed in Part 2 ]

Central Contacts and Locations

Central contacts

TRIANA Clinical Trials

medical@trianabio.com

Locations

UCSF

Recruiting

San Francisco, California, United States, 94158

Principal Investigator:

Collin Blakely, MD

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Emily Adam

303-724-8843 emily.adam@cuanschutz.edu

Principal Investigator:

Kyle Concannon, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jessica Lin, MD

617-724-4000 jjlin1@mgb.org

Principal Investigator:

Jessica Lin, MD

Dana Farber Cancer Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Alice Shaw, MD

877-442-3324 dfcitopreferrals@dfci.harvard.edu

Principal Investigator:

Alice Shaw, MD

Washington University Medical Center

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Gina Vellequette

314-362-0872 g.vellequette@wustl.edu

Principal Investigator:

Saiama Waqar, MD

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Memorial Sloan Kettering Cancer Center

646-608-3758

Principal Investigator:

Alexander Drilon, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710-2000

Principal Investigator:

Thomas Stinchcombe, MD

University of Cincinnati Cancer Center

Recruiting

Cincinnati, Ohio, United States, 45221

Principal Investigator:

Jennifer Leddon, MD

Taylor Cancer Research Center

Recruiting

Maumee, Ohio, United States, 43537

Contacts

Stephanie Ambrose

567-402-4500 sambrose@tcrcpt.org

Principal Investigator:

John Nemunaitis, MD

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Principal Investigator:

Lisa Villaruz, MD

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

AskSarah

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

Principal Investigator:

Melissa Johnson, MD

Oncology Consultants Research (P1 Trials)

Recruiting

Houston, Texas, United States, 77030

Contacts

Julio Peguero, MD

713-600-0071 jpeguero@oncologyconsultants.com

Principal Investigator:

Julio Peguero, MD

START-Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

Contacts

HOPE Team

801-907-4750 hopeteam@startresearch.com

Principal Investigator:

José Pacheco, MD

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator:

Alexander Spira, MD

More Information

Sponsor

TRIANA Biomedicines, Inc.

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by TRIANA Biomedicines, Inc. on 2026-09-03.