Condition: Chronic Myeloid Leukemia, Chronic Phase · Chronic Myeloid Leukemia · Sponsor: Terns, Inc.
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 tria…
This description comes directly from the study's public registry record.
Study Director · 650-525-5535 · clinicaltrials@ternspharma.com
Always discuss trial participation with your own doctor first.
| University of Alabama Medicine (UAB Medicine) | Birmingham, Alabama, United States | Recruiting |
| Banner MD Anderson Cancer Center | Gilbert, Arizona, United States | Recruiting |
| UC Irvine Health | Orange, California, United States | Recruiting |
| Rocky Mountain Cancer Centers, LLP | Lone Tree, Colorado, United States | Recruiting |
| Florida Cancer Specialists - South Region Research Office | Fort Myers, Florida, United States | Not Yet Recruiting |
| Florida Cancer Affiliates - Ocala | Ocala, Florida, United States | Recruiting |
| Florida Cancer Specialists - North Region Research Office | St. Petersburg, Florida, United States | Not Yet Recruiting |
| Florida Cancer Specialists - East Region Research Office | West Palm Beach, Florida, United States | Not Yet Recruiting |
| Georgia Cancer Center at Augusta University | Augusta, Georgia, United States | Recruiting |
| Memorial Sloan Kettering Cancer Center - Main Campus | New York, New York, United States | Recruiting |
| Atrium Health Levine Cancer Institute | Winston-Salem, North Carolina, United States | Recruiting |
| Willamette Valley Cancer Institute and Research Center | Eugene, Oregon, United States | Recruiting |
+ 42 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06163430