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

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: *

Trial Details

NCT ID
NCT07491497
Phase
PHASE1 / PHASE2
Sponsor
TRIANA Biomedicines, Inc.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • TRI-611
Locations (sample)
  • Aurora, Colorado, United States|39.72943,-104.83192
  • St Louis, Missouri, United States|38.62727,-90.19789
  • New York, New York, United States|40.71427,-74.00597
  • Maumee, Ohio, United States|41.56283,-83.65382
  • Nashville, Tennessee, United States|36.16589,-86.78444

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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