First Time in Humans (FTIH) Study of GSK3368715 in Subjects With Solid Tumors and Diffuse Large B-cell Lymphoma (DLBCL)

Study Overview

Arginine methylation mediated by protein arginine methyl-transferases (PRMTs) is an important post-translational modification of proteins involved in a diverse range of cellular processes. Misregulation and overexpression of PRMT1 (a type I PRMT) has been associated with a number of solid and hematopoietic cancers. GSK3368715 leads to inhibition of tumor cell growth across tumor types with cytotoxic response observed in lymphoma, acute myeloid leukemia (AML) and a subset of solid tumor cell lines. This study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK33368715 in subjects with relapsed/refractory DLBCL and selected solid tumors with frequent methyl-thioadenosine phosphorylase (MTAP)-deficiency. The study will consist of two parts. In Part 1 (Dose Escalation) escalating doses of GSK3368715 will be evaluated and recommended phase 2 dose (RP2D) will be established in subjects with selected solid relapsed/refractory tumors. In Part 2 (Dose Expansion), this RP2D will be further investigated in two expansion cohorts; subjects with DLBCL (Expansion Cohort 2A) and relapsed/refractory solid tumors including pancreatic, bladder, and non-small cell lung cancer (NSCLC)(Expansion Cohort 2B). The study includes a screening period, an intervention period and follow up. Approximately 40 subjects will be enrolled in Part 1 and 141 will be enrolled in Part 2.

Study Description

A phase I, open-label, dose-escalation study to investigate the safety,pharmacokinetics, pharmacodynamics and clinical activity of GSK3368715 in participants with solid tumors and DLBCL

  • ClinicalTrials.gov Identifier: NCT03666988
  • Protocol Number: 18-587
  • Principal Investigator: Gerburg Wulf
  • Principal Investigator: Central PIO

Recruitment Status

Open

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