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Recruiting
NCT06163430
A Clinical Study of MK-4208/TERN-701 in Participants With Chronic Myeloid Leukemia (CML) (MK-4208-003/Tern701-1012/CARDINAL)
Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Chronic Myeloid Leukemia, Chronic Phase, Chronic Myeloid Leukemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 330
Sponsor: Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Location: University of Alabama Medicine (UAB Medicine) Birmingham Alabama
Summary
Researchers are looking for a new way to treat a blood cancer called chronic myeloid leukemia (CML). Researchers want to learn if MK-4208 (Tern-701) can treat this type of blood cancer.
The goal of this study is to learn about the safety of different doses (amounts) of MK-4208 (Tern-701) and if people tolerate them. Researchers also want to find the highest dose of MK-4208 (Tern-701) that people can tolerate and may work to treat blood cancer.
Eligibility Criteria
Key Inclusion Criteria:
Inclusion Criteria include but are not limited to:
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* Have an established cytopathologically confirmed diagnosis of breakpoint cluster region::Abelson (BCR-ABL1) positive Chronic Myeloid Leukemia (CML) in Chronic Phase
* Have received treatment with at least one prior tyrosine kinase inhibitor (TKI) and have treatment failure, suboptimal response, or treatment intolerance
* Prior treatment with asciminib is allowed
* Adequate organ function, as assessed by local laboratory
Key Exclusion Criteria:
Exclusion criteria include but are not limited to:
* Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, chemotherapy) or other experimental therapy 7 days before the first dose of MK-4208/TERN-701
* Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to ≤ Grade 2 or baseline)
Source: ClinicalTrials.gov (NCT06163430). StuddyBuddy aggregates publicly available trial information.