CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 54 enrolled
Drug / intervention
GSK1795091 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03447314
NCT03447314Phase 1Completed

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

GlaxoSmithKline·interventional·Posted Feb 27, 2018·Updated Sep 23, 2024

In Brief

A Phase 1 clinical trial evaluating GSK1795091, GSK3174998, and 2 other interventions for Neoplasms. Completed, enrolled 54 participants across 8 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesCanada, Netherlands, Spain, United States
CollaboratorsIQVIA Pty Ltd

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedFeb 27, 2018
Enrollment StartMar 26, 2018
Primary CompletionJul 1, 2020
Study CompletionMar 11, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.3 years ago

Interventions

GSK1795091drug

GSK1795091 will be available as solution for injection

GSK3174998drug

GSK3174998 will be available as lyophilized powder to be reconstituted for infusion.

GSK3359609drug

GSK3359609 will be available as solution for infusion.

Pembrolizumabdrug

Pembrolizumab will be available as solution for infusion or lyophilized powder for reconstitution.