A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants with Chronic Myeloid Leukemia
A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants with Chronic Myeloid Leukemia
A study to evaluate the safety and tolerability of TERN-701 in participants with previously
treated CP-CML.
Inclusion Criteria:
1. Male or female participants ? 18 years of age at the time of signing the informed consent
2. Have an ECOG performance status score of 0 to 2
3. Have an established cytopathologically confirmed diagnosis of BCR::ABL1 positive CML in CP, and meet at least one of the following:
? Participants without the BCR::ABL1 T315Im, who meet one of the following and have experienced treatment failure, suboptimal response, or treatment intolerance as determined by the investigator. o Received 2 or more active site targeting TKIs OR
o Received frontline therapy with dasatinib, nilotinib, or bosutinib and are ineligible for alternative TKIs per the investigator?s discretion
In Part 1 only, participants with BCR::ABL1 T315Im who received 1 or more active site
targeting TKIs
Participants who are intolerant of asciminib
Exclusion criteria:
1. Has known ABL1 myristoyl domain resistance mutations
2. Has CML in accelerated or blast phase
3. For Part 2 only, CML with T315I mutation