Study on the Safety and Effectiveness of TERN-701 for Treating Chronic Myeloid Leukemia
Sponsor: Terns, Inc.
ClinicalTrials ID:NCT06163430
This clinical trial is testing a new medication, TERN-701, to see if it is safe and effective for people with chronic myeloid leukemia (CML) who have already received treatment. The study will explore different doses to find the best one for patients.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how safe and effective TERN-701 is for treating chronic myeloid leukemia (CML) in patients who have already been treated before. TERN-701 is a new type of medication that targets a specific protein involved in CML. The study is divided into two parts: the first part will test different doses to find the safest and most effective one, while the second part will further test the best doses found in the first part. Participants will take TERN-701 daily in 28-day cycles and will have regular visits to the trial center for check-ups.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a performance status score between 0 and 2, indicating good overall health.
- Have a confirmed diagnosis of chronic myeloid leukemia (CML) in the chronic phase with a specific genetic marker (BCR-ABL1 positive).
- Have previously been treated with at least one tyrosine kinase inhibitor (TKI) and experienced treatment failure, suboptimal response, or intolerance.
- Previous treatment with asciminib is allowed.
- Have adequate organ function as determined by lab tests.
Exclusion Criteria
- Have received any cancer treatment, including TKIs, interferon-alfa, therapeutic antibodies, or chemotherapy, within 7 days before starting TERN-701.
- Have unresolved side effects from previous cancer treatments that are more than mild (greater than Grade 2 severity).
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama Medicine (UAB Medicine) | 35233 | Birmingham | Alabama |
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| UC Irvine Health | 92868 | Orange | California |
| Rocky Mountain Cancer Centers, LLP | 80303 | Lone Tree | Colorado |
| Florida Cancer Specialists - South Region Research Office | 33901 | Fort Myers | Florida |
| Florida Cancer Affiliates - Ocala | 34474 | Ocala | Florida |
| Florida Cancer Specialists - North Region Research Office | 33705 | St. Petersburg | Florida |
| Florida Cancer Specialists - East Region Research Office | 33401 | West Palm Beach | Florida |
| Georgia Cancer Center at Augusta University | 30912 | Augusta | Georgia |
| Memorial Sloan Kettering Cancer Center - Main Campus | 10065 | New York | New York |
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