A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia

Inclusion Criteria:

• BCR-ABL1 positive CML in chronic phase, with or without T315I mutation.

• US: The patient has failed or is intolerant to at least one prior second-generationtyrosine kinase inhibitor (TKI) or asciminib. Rest of World: The patient has failed,is intolerant to, or not a candidate for, available therapies known to be active fortreatment of their CML (country-specific criteria may vary).

• ECOG performance status of 0 to 2.

• Adequate hematologic, hepatic and renal function.

• Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose ofELVN-001.

Exclusion Criteria:

• Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives,whichever is longer.

• History of acute tyrosine kinase inhibitor (TKI)-related pancreatitis within 6months of study entry. Active chronic pancreatitis, or pancreatic disease due to anycause.

• QTc >470 ms.