Summary
You may be eligible for this study if you have BCR-ABL1 positive chronic myeloid leukaemia (CML) in Chronic Phase, and have received treatment with at least one prior TKI and have treatment failure, suboptimal response, or treatment intolerance.
Study details
The study has two parts. All participants in this trial will receive the active experimental intervention of TERN-701 targeted therapy. In both Part 1 and Part 2, participants will receive continuous once daily dosing of TERN-701 divided into 28-day cycles.
Part 1 of the trial (Dose Escalation) will evaluate sequential dose escalation cohorts of the TERN-701 administered once daily as an oral tablet or capsule. The goal of this part is to identify the recommended doses of the drug for further assessment.
In Part 2 (Dose Expansion), eligible participants will be randomly allocated to receive one of the two dose levels selected in Part 1.
Part 2 will also have a mutaytion cohort (Part 2m), which will evaluate the TERN-701 in people with previously treated CP-CML who have certain resistance mutations.
Site visits required
During the treatment period, participants will have scheduled visits to the trial centre at Cycle 1 Day 1 (C1D1), C1D2 (Part 1 only), C1D8, C1D15, and C1D16 (Part 1 only), followed by Day 1 of Cycles 2-7, an Day 1 of every 3 cycles thereafter.