Clinical trial · Interventional
Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
A Phase I/II Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents in Participants With Myelodysplastic Syndrome and Acute Myeloid Leukaemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Trial terminated due to internal review of clinical data in context of indication under investigation
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Azacitidine | Drug | Azacitidine | ALIAS |
| GSK3326595 | Drug | Pemrametostat | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1: Participants receiving GSK3326595
- interventionNames
- Drug: GSK3326595
- type
- EXPERIMENTAL
- label
- Part 2 Dose escalation : Participants receiving GSK3326595+5-Azacitidine
- interventionNames
- Drug: GSK3326595
- Drug: 5-Azacitidine
- type
- EXPERIMENTAL
- label
- Part 2 Dose expansion: Participants receiving GSK3326595+5-Azacitidine
- interventionNames
- Drug: GSK3326595
- Drug: 5-Azacitidine
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWatts J, Minden MD, Bachiashvili K, Brunner AM, Abedin S, Crossman T, Zajac M, Moroz V, Egger JL, Tarkar A, Kremer BE, Barbash O, Borthakur G. Phase I/II study of the clinical activity and safety of GSK3326595 in patients with myeloid neoplasms. Ther Adv Hematol. 2024 Sep 14;15:20406207241275376. doi: 10.1177/20406207241275376. eCollection 2024. PMID 39290981