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

ClinicalTrials.gov ID: NCT07491497

Public ClinicalTrials.gov record NCT07491497. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 11:42 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT07491497
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: TRIANA Biomedicines, Inc.; Industry
Enrollment: 160 participants

Conditions and interventions

Conditions

Interventions

TRI-611 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 10, 2026
Primary completion: May 30, 2029
Completion: Jan 29, 2034
Last update posted: Sep 2, 2026

2026 – 2034

United States locations

U.S. sites: 14
U.S. states: 12
U.S. cities: 13

Facility	City	State	ZIP	Site status
UCSF	San Francisco	California	94158	Recruiting
University of Colorado Cancer Center	Aurora	Colorado	80045	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	02114	Recruiting
Dana Farber Cancer Center	Boston	Massachusetts	02215	Recruiting
Washington University Medical Center	St Louis	Missouri	63130	Recruiting
Memorial Sloan-Kettering Cancer Center	New York	New York	10065	Recruiting
Duke University	Durham	North Carolina	27710-2000	Recruiting
University of Cincinnati Cancer Center	Cincinnati	Ohio	45221	Recruiting
Taylor Cancer Research Center	Maumee	Ohio	43537	Recruiting
UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	15213	Recruiting
SCRI Oncology Partners	Nashville	Tennessee	37203	Recruiting
Oncology Consultants Research (P1 Trials)	Houston	Texas	77030	Recruiting
START-Mountain Region	West Valley City	Utah	84119	Recruiting
NEXT Virginia	Fairfax	Virginia	22031	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07491497, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 2, 2026 · Synced Sep 5, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07491497 live on ClinicalTrials.gov.

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