A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL) (NCT06163430)
A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia
🩺 Plain-English Summary (8th-Grade Level)
The goal of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TERN-701, a highly selective allosteric inhibitor of BCR-ABL1, in participants with previously treated chronic phase - chronic myeloid leukemia (CP-CML). The study has two parts: Part 1 of the trial (Dose Escalation) will evaluate sequential dose escalation cohorts of TERN-701 administered once daily. Part 2 (Dose Expansion) consists of randomized, parallel dose expansion cohorts of TERN-701 that will further evaluate the efficacy and safety of 2 recommended dose levels for expansion selected from Part 1. Part 2m (mutation cohort) will further evaluate the efficacy and safety of 500mg of TERN-701 in previously treated CP-CML participants with certain resistance mutations. In both Part 1 and Part 2, participants will receive continuous once daily dosing of TERN-701 divided into 28-day cycles. During the treatment period, participants will have scheduled visits to the trial center at Cycle 1 day 1(C1D1), C1D2 (Part 1 only), C1D8, C1D15, and C1D16 (Part 1 only), followed by Day 1 of Cycles 2 through 7, and Day 1 of every 3 cycles thereafter. Approximately 180 participants could be enrolled in this trial, up to 80 participants in Part 1 (dose escalation), including optional backfill cohorts, approximately 80 participants in Part 2 (randomized dose expansion), and approximately 20 participants in Part 2m (mutation cohort). All participants will receive active trial intervention. Four dose-level cohorts have been evaluated in Part 1; two dose levels will be evaluated in Part 2 (Randomized Dose Expansion), and one dose level will be evaluated in Part 2m (mutation cohort).
Who can join: Review the eligibility criteria below.
Location: University of Alabama Medicine (UAB Medicine) — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (54 Sites)
Showing the first 25 of 54 sites.
- University of Alabama Medicine (UAB Medicine) — Birmingham, Alabama
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- UC Irvine Health — Orange, California
- Rocky Mountain Cancer Centers, LLP — Lone Tree, Colorado
- Florida Cancer Specialists - South Region Research Office — Fort Myers, Florida
- Florida Cancer Affiliates - Ocala — Ocala, Florida
- Florida Cancer Specialists - North Region Research Office — St. Petersburg, Florida
- Florida Cancer Specialists - East Region Research Office — West Palm Beach, Florida
- Georgia Cancer Center at Augusta University — Augusta, Georgia
- Memorial Sloan Kettering Cancer Center - Main Campus — New York, New York
- Atrium Health Levine Cancer Institute — Winston-Salem, North Carolina
- Willamette Valley Cancer Institute and Research Center — Eugene, Oregon
- Oregon Health & Science University — Portland, Oregon
- Thomas Jefferson University - Center City (Philadelphia) — Philadelphia, Pennsylvania
- Tristar BMT — Nashville, Tennessee
- The University of Texas M.D. Anderson Cancer Center — Houston, Texas
- Huntsman Cancer Institute — Salt Lake City, Utah
- Fred Hutchinson Cancer Center — Seattle, Washington
- Royal Adelaide Hospital — Adelaide, South Australia
- Monash Medical Centre — Clayton, Victoria
- Peter MacCallum Cancer Centre — Melbourne, Victoria
- Royal Perth Hospital — Perth, Western Australia
- Centre Léon Bérard — Lyon, Auvergne-Rhône-Alpes
- Institut Bergonié — Bordeaux,
- Institut Paoli Calmettes — Marseille,
📞 Contact the Study Coordinator
Phone: (650) 525-5535
Email: clinicaltrials@ternspharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 § 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.