RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: TRIANA Biomedicines, Inc. • ClinicalTrials.gov ID: NCT07491497

Registry updated: 2026-09-03

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Description

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

Interventions

TRI-611 (Drug)
oral ALK molecular glue degrader

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

Conditions

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

Locations

UCSF — San Francisco, California, United States
University of Colorado Cancer Center — Aurora, Colorado, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Dana Farber Cancer Center — Boston, Massachusetts, United States
Washington University Medical Center — St Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Duke University — Durham, North Carolina, United States
University of Cincinnati Cancer Center — Cincinnati, Ohio, United States
Taylor Cancer Research Center — Maumee, Ohio, United States
UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
SCRI Oncology Partners — Nashville, Tennessee, United States
Oncology Consultants Research (P1 Trials) — Houston, Texas, United States
START-Mountain Region — West Valley City, Utah, United States
NEXT Virginia — Fairfax, Virginia, United States
Royal North Shore Hospital — Sydney, New South Wales, Australia
Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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