Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This study will evaluate the safety, tolerability, and clinical activity of GSK3326595 in
participants with relapsed and refractory MDS, chronic myelomonocytic leukemia (CMML), and
AML. The study will be conducted in 2 parts: Part 1 will determine the clinical benefit rate
(CBR) of GSK3326595 in monotherapy and Part 2 will be expanded to study GSK3326595 in
combination with 5-Azacitidine which will be composed of a dose escalation phase followed by
dose expansion cohort of GSK3326595.
Phase
Phase 1/Phase 2
Funding Agency/Sponsor
Industrial
Disease
Leukemia/heme
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.