A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC
Recruiting · NCT07491497 · Interventional (participants receive a specific treatment) · Lead sponsor: TRIANA Biomedicines, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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
Where it is running
16 locations listed across 12 US states.
- 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