๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-24

A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC (NCT07491497)

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

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: TRIANA Biomedicines, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 join: Review the eligibility criteria below.

Location: UCSF โ€” San Francisco, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (12 Sites)

  • UCSF โ€” San Francisco, California
  • University of Colorado Cancer Center โ€” Aurora, Colorado
  • Massachusetts General Hospital โ€” Boston, Massachusetts
  • Dana Farber Cancer Center โ€” Boston, Massachusetts
  • Washington University Medical Center โ€” St Louis, Missouri
  • Memorial Sloan-Kettering Cancer Center โ€” New York, New York
  • Duke University โ€” Durham, North Carolina
  • Taylor Cancer Research Center โ€” Maumee, Ohio
  • SCRI Oncology Partners โ€” Nashville, Tennessee
  • Oncology Consultants Research (P1 Trials) โ€” Houston, Texas
  • START Mountain Region โ€” West Valley City, Utah
  • NEXT Virginia โ€” Fairfax, Virginia

๐Ÿ“ž Contact the Study Coordinator

Phone: (877) 827-3222

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—