Clinical Trial Summary

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Phase

Phase 1/Phase 2

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Funding Agency/Sponsor

Industrial

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Disease

Leukemia/heme

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Enrollment Eligibility

Inclusion Criteria:
- Males and females greater than or equal to (>=)18 years of age (at the time consent is
obtained).
- Diagnosis of MDS, CMML or AML
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2
- Adequate organ function
- A woman of childbearing potential (WOCBP) must have a negative highly sensitive serum
pregnancy test within 7 days before the first dose of study intervention.
Exclusion Criteria:
- History of, or known, central nervous system (CNS) involvement
- Prior solid organ transplantation
- Known allergies, hypersensitivity, or intolerance to GSK3326595 or 5-Azacitidine or
its excipient
- Prior therapy with any Protein arginine methyl transferase 5 (PRMT5) inhibitor
- History of a second malignancy, excluding non-melanoma skin cell cancer, within the
last three years
- Active severe or uncontrolled infection
- History of optic nerve neuropathy or neuritis.
- History of sensitivity to any of the study medications, or components thereof, or a
history of drug or other allergy that, in the opinion of the investigator or Medical
Monitor, contraindicates their participation.

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