Clinical trial · Interventional
An Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Participants With Solid Tumors and Non-Hodgkin's Lymphoma
A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Subjects With Solid Tumors and Non-Hodgkin's Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This first time in human (FTIH) open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and non-Hodgkin's lymphoma (NHL).
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 |
|---|---|---|---|
| GSK3326595 | Drug | Pemrametostat | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1: Dose Escalation, Food effect and Relative Bioavailability of Capsule formulation to Tablet
- description
- Participants will receive escalating doses of GSK3326595 until the maximum tolerated dose level is reached. The recommended phase 2 dose (RP2D) will be determined. Participants will be dosed in a fed (high-fat, high-calorie meal) and fasted state to determine the effect of food on bioavailability of GSK3326595, and will be dosed with tablet and capsule to compare two formulations of GSK3326595 (capsule versus tablet).
- interventionNames
- Drug: GSK3326595
- type
- EXPERIMENTAL
- label
- Part 2: Disease-Specific Expansion cohort
- description
- Participants with triple-negative breast cancer (TNBC), metastatic transitional cell carcinoma of the urinary system (mTCC), Grade IV anaplastic astrocytoma (glioblastoma multiforme \[GBM\]), non-Hodgkin's lymphoma (NHL), adenoid cystic carcinoma (ACC), hormone receptor-positive adenocarcinoma of the breast (ER+BC), human papillomavirus (HPV)-positive solid tumors of any histology, and p53-wild type non-small cell lung cancer (NSCLC) will be administered GSK3326595 at the recommended phase 2 dose (RP2D) as determined in Part 1.
- interventionNames
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) * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2 * Diagnosis of non-resectable or metastatic solid malignancy (as defined in the protocol) or NHL * Presence of evaluable disease * Adequate organ function (as defined in the protocol) * Reproductive criteria (as defined in the protocol). Exclusion Criteria: * Malignancy attributed to prior solid organ transplant * Leptomeningeal disease, spinal cord compression, or brain metastases that require immediate central nervous system (CNS)-specific treatment in the opinion of the Investigator (for example \[e.g.\], for symptomatic disease) * History of a second malignancy, excluding non-melanoma skin cell cancer within the last three years * Evidence of severe or uncontrolled systemic diseases, or serious and/or pre-existing medical or other condition that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator * Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels. * Select cardiac abnormalities (as defined in the protocol) * 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. * History of optic nerve neuropathy or neuritis.
References
Publications (1)
- DERIVEDGounder MM, Martin-Romano P, Italiano A, Siu LL, Cassier PA, Falchook GS, Lossos IS, Rasco DW, Hilton JF, McKean MA, Opdam FL, Strauss J, De Jonge M, Vermaat JSP, Crossman T, Zajac M, Tarkar A, Gonzalez Carreras F, Kremer BE, Barbash O, Segal S, Parasrampuria R, Postel-Vinay S. Phase Ib and dose-expansion study of GSK3326595, a PRMT5 inhibitor as monotherapy and in combination with pembrolizumab in patients with advanced cancers. Ann Oncol. 2025 Dec;36(12):1480-1491. doi: 10.1016/j.annonc.2025.08.3757. Epub 2025 Sep 9. PMID 40935292