A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)

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 expan

Trial Details

NCT ID
NCT06163430
Phase
PHASE1 / PHASE2
Sponsor
Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • TERN-701
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Orange, California, United States|33.78779,-117.85311
  • Lone Tree, Colorado, United States|39.55171,-104.8863
  • Fort Myers, Florida, United States|26.62168,-81.84059

Key Eligibility Criteria

  • Male or female participants ≥ 18 years of age at the time of signing the informed consent
  • Have an ECOG performance status score of 0 to 2
  • Have an established cytopathologically confirmed diagnosis of BCR-ABL1 positive CML in Chronic Phase
  • Have received treatment with at least one prior TKI and have treatment failure, suboptimal response, or treatment intolerance

For full eligibility, visit ClinicalTrials.gov.

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