Study on TRI-611 for ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
Sponsor: TRIANA Biomedicines, Inc.
ClinicalTrials ID:NCT07491497
This clinical trial is testing a new drug, TRI-611, to find the safest and most effective dose for treating adults with ALK-positive non-small cell lung cancer (NSCLC). The study will also assess how well TRI-611 works in shrinking tumors.
Patient Parameters
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Program Overview
The purpose of this study is to determine the safety and best dose of TRI-611 for adults with ALK-positive non-small cell lung cancer (NSCLC). The trial will be conducted in two parts. The first part will test different doses of TRI-611 to find the most suitable one. The second part will evaluate how well TRI-611 works in three groups of participants, based on their previous treatments. Participants will take TRI-611 regularly as long as it is well-tolerated and their cancer is not worsening. They will visit the clinic about seven times in the first three months and then once at the start of each 28-day cycle. Participants will also keep a diary of when they take the medication.
Description
This study is divided into two phases: Phase 1 and Phase 2. In Phase 1, researchers will test different doses of TRI-611 to find the safest and most effective dose for further study. This phase will help determine the maximum tolerated dose (MTD) and the recommended dose for Phase 2.
In Phase 2, the study will focus on how well TRI-611 works in treating ALK-positive NSCLC. Participants will be divided into three groups based on their previous treatments with ALK inhibitors. The study will explore the antitumor effects of TRI-611 in these groups.
Participants will take TRI-611 continuously if it is well-tolerated and their cancer does not progress. They will have regular clinic visits and will need to keep a diary of their medication intake.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with ALK-positive non-small cell lung cancer (NSCLC).
- Have measurable cancer according to specific medical criteria.
- Have adequate bone marrow and organ function.
- For Part 1: Previously treated with 2 to 3 ALK inhibitors, including lorlatinib, but not as the first treatment.
- For Part 2 Cohort M1: Previously treated with 2 to 3 ALK inhibitors, including lorlatinib, but not as the first treatment, and not treated with neladalkib.
- For Part 2 Cohort M2: Previously treated with more than 3 ALK inhibitors, including lorlatinib and neladalkib, but neither as the first treatment.
- For Part 2 Cohort M3: No prior treatment with ALK inhibitors.
Exclusion Criteria
- Cancer has other genetic changes that make it resistant to ALK inhibitors.
- Have brain or spinal cord cancer that causes worsening symptoms or requires increasing doses of steroids.
- Currently receiving another cancer treatment or investigational drug.
- Known allergy to TRI-611 or its ingredients.
- Had major surgery within 4 weeks before starting TRI-611.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Colorado Cancer Center | 80045 | Aurora | Colorado |
| Washington University Medical Center | 63130 | St Louis | Missouri |
| Memorial Sloan-Kettering Cancer Center | 10065 | New York | New York |
| Taylor Cancer Research Center | 43537 | Maumee | Ohio |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| START Mountain Region | 84119 | West Valley City | Utah |
| NEXT Virginia | 22031 | Fairfax | Virginia |
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