Study of a Combination of GSK1795091 and Immunotherapies in Subjects With Advanced Solid Tumors

Summary

GSK1795091 is being developed for administration in combination with other immune system modulators for the treatment of cancers. The study will be conducted in two parts. In Part 1, dose escalation will be performed to identify combination dose levels comprising GSK1795091 with either 24 milligrams (mg) GSK3174998 (Part 1a), 80 mg GSK3359609 (Part 1b), or 200 mg pembrolizumab (Part 1c). One dose level of GSK3174998, GSK3359609, or pembrolizumab with up to 5 dose levels of GSK1795091 are planned for evaluation. In Part 2 (dose-expansion), subjects will receive a single dose level of GSK1795091 as identified based on data from Part 1, in combination with either GSK3174998, GSK3359609, or pembrolizumab.

Timeline

Start

2018-03-26

Primary completion

2020-07-01

Completion

2022-03-11

Publications

• Steeghs N, Hansen AR, Hanna GJ, Garralda E, Park H, Strauss J, Adam M, Campbell G, Carver J, Easton R, Mays K, Skrdla P, Struemper H, Washburn ML, Matheny C, Piha-Paul SA. Manufacturing-dependent change in biological activity of the TLR4 agonist GSK1795091 and implications for lipid A analog development. Clin Transl Sci. 2022 Nov;15(11):2625-2639. doi: 10.1111/cts.13387. Epub 2022 Sep 12.

Drugs

Indications