Status:
RECRUITING
CARDINAL- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia
Lead Sponsor:
Terns, Inc.
Conditions:
Chronic Myeloid Leukemia, Chronic Phase
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TERN-701, a novel highly selective allosteric inhibitor of BCR-ABL1, in participants w...
Eligibility Criteria
Inclusion
- Key
- 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 active site targeting TKIs and have treatment failure, suboptimal response, or treatment intolerance
- Prior treatment with asciminib may be allowed
- Adequate organ function, as assessed by local laboratory
- Key
Exclusion
- Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, chemotherapy) or other experimental therapy 7 days before the first dose of TERN-701
- Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to ≤ Grade 2 or baseline)
Key Trial Info
Start Date :
March 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06163430
Start Date
March 26 2024
End Date
May 31 2026
Last Update
July 16 2025
Active Locations (40)
Enter a location and click search to find clinical trials sorted by distance.
1
UC Irvine Health
Orange, California, United States, 92868
2
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States, 80303
3
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
4
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States, 10065