Actively Recruiting
A Phase 1/2 Dose Escalation and Expansion Study of TRI-611, an Oral ALK Molecular Glue Degrader in Adults With Advanced ALK-Positive NSCLC
Led by TRIANA Biomedicines, Inc. · Updated on 2026-05-07
160
Participants Needed
7
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying TRI-611, an oral ALK molecular glue degrader, to learn about its safety, recommended dose, and how it works against ALK-positive non-small cell lung cancer (NSCLC) in adults. This Phase 1/2 trial aims to find the best dose for further studies and evaluate the antitumor activity of TRI-611 in different groups of patients based on their prior treatments with ALK tyrosine kinase inhibitors (TKIs). The study has two parts. The first part focuses on escalating doses of TRI-611 to determine the maximum tolerated dose and recommended phase 2 dose. The second part involves three groups of participants who have received different previous ALK TKI treatments, including lorlatinib and neladalkib, to explore the drug's antitumor effects. Participants will take TRI-611 continuously as long as their disease does not progress. Participants will visit the clinic about seven times during the first three months and then once every 28-day cycle afterward. They are asked to keep a diary of their medication intake. Researchers will monitor safety by tracking treatment-emergent adverse events and measure how well the cancer responds using objective response rates and depth of response. The study includes long-term follow-up for up to five years to observe response duration, disease control, survival, and effects on the central nervous system.
CONDITIONS
Brief Title
A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with ALK-positive non-small cell lung cancer confirmed by pathology
- Measurable disease according to RECIST v1.1 criteria
- Adequate bone marrow reserve and organ function
- Part 1: Previously treated with 2 to 3 ALK tyrosine kinase inhibitors, including lorlatinib but not as first treatment
- Part 2 Cohort M1: Previously treated with 2 to 3 ALK TKIs including lorlatinib (not first line), excluding neladalkib
- Part 2 Cohort M2: Previously treated with more than 3 ALK TKIs including lorlatinib and neladalkib (neither as first line)
- Part 2 Cohort M3: No prior ALK TKI treatment
- Adults aged 18 years or older
You will not qualify if you...
- Cancer has additional driver alterations that cause resistance to ALK TKIs
- Central nervous system metastases or spinal cord compression with progressive neurological symptoms or requiring increasing corticosteroids
- Currently receiving other anticancer treatments or investigational agents
- Known allergy or hypersensitivity to TRI-611 or its ingredients
- Major surgery within 4 weeks before first dose of TRI-611
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated cycles until disease progression or discontinuation
Participants receive the study drug TRI-611 orally to evaluate safety, tolerability, and antitumor activity in ALK-positive NSCLC.
Regular visits during dosing cycles for assessments and monitoring
Duration - Up to approximately 5 years after last dose
Participants are monitored for long-term safety, response duration, progression-free survival, and overall survival after treatment ends.
Periodic follow-up visits for up to 5 years
Trial Site Locations
Total: 7 locations
1
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Washington University Medical Center
St Louis, Missouri, United States, 63130
Actively Recruiting
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
4
Taylor Cancer Research Center
Maumee, Ohio, United States, 43537
Actively Recruiting
5
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
6
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
7
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
T
TRIANA Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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