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

Phase 1 Completed 297 enrolled GlaxoSmithKline

Non-randomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start: 2016-08-30
Primary completion: 2023-08-30
Completion: 2023-08-30

Publications

Gounder 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PEMRAMETOSTAT	Small molecule	12.5 mg	Oral
Subject	PEMRAMETOSTAT	Small molecule	100 mg	Oral
Subject	PEMRAMETOSTAT	Small molecule	200 mg	Oral
Subject	PEMRAMETOSTAT	Small molecule	300 mg	Oral
Subject	PEMRAMETOSTAT	Small molecule	400 mg	Oral
Subject	PEMRAMETOSTAT	Small molecule	600 mg	Oral
Background	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications