TRI-611 for ALK-positive non-small cell lung cancer (Phase 1/2)
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
PHASE1; PHASE2 · TRIANA Biomedicines, Inc. · NCT07491497
This trial will test TRI-611 to see if it is safe and can shrink tumors in adults with ALK-positive non-small cell lung cancer, including people with different past ALK treatments.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | TRIANA Biomedicines, Inc. (industry) |
| Drugs / interventions | lorlatinib |
| Locations | 7 sites (Aurora, Colorado and 6 other locations) |
| Trial ID | NCT07491497 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1/2 dose-escalation and expansion trial giving TRI-611 continuously to adults with ALK-positive NSCLC to determine the maximum tolerated or recommended Phase 2 dose and to describe safety. Part 1 uses dose escalation (with backfill cohorts) to identify the MTD/RP2D, and Part 2 enrolls three cohorts defined by prior ALK TKI treatment to measure antitumor activity. Participants take TRI-611 regularly if tolerated, keep a dosing diary, have frequent clinic visits in the first three months, and then clinic visits once every 28-day cycle. Tumor response will be assessed by RECIST v1.1 and safety monitored with labs and clinical exams.
Who should consider this trial
Good fit: Adults with pathologically confirmed ALK-positive NSCLC, measurable disease, adequate organ and marrow function, and prior ALK TKI exposure matching the cohort definitions (from treatment-naïve to multiple prior ALK TKIs) are the intended candidates.
Not a fit: Patients whose tumors have additional driver alterations known to cause resistance to ALK TKIs, those with uncontrolled CNS metastases or spinal cord compression, or those with disallowed prior therapies are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, TRI-611 could offer a new targeted treatment option that controls tumor growth for people with ALK-positive NSCLC, including those who have progressed after other ALK inhibitors.
How similar studies have performed: Other ALK-targeting drugs have produced meaningful tumor control in ALK-positive NSCLC, but TRI-611 is an investigational agent and its clinical benefit has not yet been established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aurora, Colorado and 6 other locations
- University of Colorado Cancer Center — Aurora, Colorado, United States (RECRUITING)
- Washington University Medical Center — St Louis, Missouri, United States (RECRUITING)
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States (RECRUITING)
- Taylor Cancer Research Center — Maumee, Ohio, United States (RECRUITING)
- SCRI Oncology Partners — Nashville, Tennessee, United States (RECRUITING)
- START Mountain Region — West Valley City, Utah, United States (RECRUITING)
- NEXT Virginia — Fairfax, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: TRIANA Clinical Trials
- Email: medical@trianabio.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ALK-positive NSCLC, ALK-Positive Lung Cancer, ALK-positive Non-small Cell Lung Cancer