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

NCT03447314 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-09-23

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-26
Primary Completion
2020-07-01
Completion
2022-03-11
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03447314 on ClinicalTrials.gov