NCT03447314

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

A Phase I, Open-Label Study of GSK1795091 Administered in Combination With Immunotherapies in Participants With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	GSK1795091	GSK1795091 will be available as solution for injection
DRUG	GSK3174998	GSK3174998 will be available as lyophilized powder to be reconstituted for infusion.
DRUG	GSK3359609	GSK3359609 will be available as solution for infusion.
DRUG	Pembrolizumab	Pembrolizumab will be available as solution for infusion or lyophilized powder for reconstitution.

Timeline

• Start date: 2018-03-26
• Primary completion: 2020-07-01
• Completion: 2022-03-11
• First posted: 2018-02-27
• Last updated: 2024-09-23
• Results posted: 2021-07-20

Locations

8 sites across 4 countries: United States, Canada, Netherlands, Spain

Regulatory

• FDA-regulated drug study