NCT02798978 is a Phase 1 clinical trial of GSK1795091 in Cancer, sponsored by GlaxoSmithKline.

Who is sponsoring NCT02798978?

NCT02798978 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT02798978?

Interventions in NCT02798978: GSK1795091, Placebo.

What condition does NCT02798978 study?

NCT02798978 studies Cancer, Neoplasms.

Is NCT02798978 still recruiting?

NCT02798978 is currently completed. Last updated 27 November 2020.

Are results published for NCT02798978?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-11-27 · How we verify

NCT02798978

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase I, 2-part (Part 1 Being a Single Dose Escalation and Part 2, a Parallel Group) Study of Toll-like Receptor (TLR4) Agonist (GSK1795091) in Healthy Subjects

Completed Phase 1 Results posted Last updated 27 November 2020

What this trial tests

Phase 1 trial testing GSK1795091 in Cancer in 42 participants. Completed in 13 October 2017.

Timeline

10 January 2017

Primary endpoint
13 October 2017

13 October 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	42
Start date	10 January 2017
Primary completion	13 October 2017
Estimated completion	13 October 2017
Sites	1 location across Germany

Drugs / interventions tested

GSK1795091 — full drug profile →
Placebo

Conditions studied

Cancer — all drugs for Cancer →
Neoplasms — all drugs for Neoplasms →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 50, any sex, with Cancer or Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) Primary · Up to Day 32

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or events associated with liver injury and impaired liver function were categorized as SAE. All participants enrolled into the study who have

Any SAE

Group	Value	95% CI
Part 1: Placebo	0
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	0
Part 1: GSK1795091 60 ng	0
Part 1: GSK1795091 Repeated 60 ng	0
Part 1: GSK1795091 100 ng	0

Non-SAE (>= 5%)

Group	Value	95% CI
Part 1: Placebo	0
Part 1: GSK1795091 7 ng	2
Part 1: GSK1795091 21 ng	0
Part 1: GSK1795091 60 ng	5
Part 1: GSK1795091 Repeated 60 ng	3
Part 1: GSK1795091 100 ng	5

Change From Baseline in Body Temperature Part 1 Primary · Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.

Body temperature was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.

Day 1, 1 hour

Group	Value	95% CI
Part 1: Placebo	0.14	± 0.084
Part 1: GSK1795091 7 ng	0.17	± 0.163
Part 1: GSK1795091 21 ng	0.08	± 0.264
Part 1: GSK1795091 60 ng	0.15	± 0.187
Part 1: GSK1795091 Repeated 60 ng	0.15	± 0.281
Part 1: GSK1795091 100 ng	0.17	± 0.327

Day 1, 2 hour

Group	Value	95% CI
Part 1: Placebo	0.17	± 0.095
Part 1: GSK1795091 7 ng	0.23	± 0.163
Part 1: GSK1795091 21 ng	0.32	± 0.232
Part 1: GSK1795091 60 ng	0.68	± 0.354
Part 1: GSK1795091 Repeated 60 ng	0.40	± 0.179
Part 1: GSK1795091 100 ng	0.87	± 0.367

Day 1, 4 hour

Group	Value	95% CI
Part 1: Placebo	0.26	± 0.196
Part 1: GSK1795091 7 ng	0.42	± 0.147
Part 1: GSK1795091 21 ng	0.55	± 0.389
Part 1: GSK1795091 60 ng	0.98	± 0.556
Part 1: GSK1795091 Repeated 60 ng	0.63	± 0.383
Part 1: GSK1795091 100 ng	1.25	± 0.295

Day 1, 6 hour

Group	Value	95% CI
Part 1: Placebo	0.43	± 0.206
Part 1: GSK1795091 7 ng	0.53	± 0.301
Part 1: GSK1795091 21 ng	0.45	± 0.464
Part 1: GSK1795091 60 ng	0.82	± 0.665
Part 1: GSK1795091 Repeated 60 ng	0.38	± 0.483
Part 1: GSK1795091 100 ng	0.93	± 0.163

Day 1, 8 hour

Group	Value	95% CI
Part 1: Placebo	0.41	± 0.197
Part 1: GSK1795091 7 ng	0.53	± 0.273
Part 1: GSK1795091 21 ng	0.43	± 0.301
Part 1: GSK1795091 60 ng	0.63	± 0.432
Part 1: GSK1795091 Repeated 60 ng	0.57	± 0.258
Part 1: GSK1795091 100 ng	0.75	± 0.389

Day 1, 12 hour

Group	Value	95% CI
Part 1: Placebo	0.14	± 0.255
Part 1: GSK1795091 7 ng	0.18	± 0.337
Part 1: GSK1795091 21 ng	0.28	± 0.397
Part 1: GSK1795091 60 ng	0.28	± 0.397
Part 1: GSK1795091 Repeated 60 ng	0.23	± 0.242
Part 1: GSK1795091 100 ng	0.67	± 0.294

Day 1, 16 hour

Group	Value	95% CI
Part 1: Placebo	0.03	± 0.258
Part 1: GSK1795091 7 ng	0.02	± 0.223
Part 1: GSK1795091 21 ng	-0.08	± 0.319
Part 1: GSK1795091 60 ng	0.03	± 0.175
Part 1: GSK1795091 Repeated 60 ng	0.03	± 0.225
Part 1: GSK1795091 100 ng	0.32	± 0.349

Day 2

Group	Value	95% CI
Part 1: Placebo	0.06	± 0.190
Part 1: GSK1795091 7 ng	-0.02	± 0.172
Part 1: GSK1795091 21 ng	-0.05	± 0.226
Part 1: GSK1795091 60 ng	0.12	± 0.147
Part 1: GSK1795091 Repeated 60 ng	-0.08	± 0.117
Part 1: GSK1795091 100 ng	0.13	± 0.186

Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 Primary · Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.

Systolic and diastolic BP was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.

DBP, Day 1, 1 hour

Group	Value	95% CI
Part 1: Placebo	-2.1	± 6.14
Part 1: GSK1795091 7 ng	-3.8	± 2.79
Part 1: GSK1795091 21 ng	-2.3	± 5.50
Part 1: GSK1795091 60 ng	-1.3	± 4.27
Part 1: GSK1795091 Repeated 60 ng	-3.2	± 5.23
Part 1: GSK1795091 100 ng	-3.3	± 4.18

DBP, Day 1, 2 hour

Group	Value	95% CI
Part 1: Placebo	-4.3	± 4.00
Part 1: GSK1795091 7 ng	-5.0	± 1.26
Part 1: GSK1795091 21 ng	-5.0	± 10.06
Part 1: GSK1795091 60 ng	-6.5	± 2.43
Part 1: GSK1795091 Repeated 60 ng	-4.8	± 3.43
Part 1: GSK1795091 100 ng	-7.0	± 8.20

DBP, Day 1, 4 hour

Group	Value	95% CI
Part 1: Placebo	-1.9	± 4.77
Part 1: GSK1795091 7 ng	-3.8	± 3.54
Part 1: GSK1795091 21 ng	-3.7	± 5.05
Part 1: GSK1795091 60 ng	-3.7	± 5.82
Part 1: GSK1795091 Repeated 60 ng	-4.5	± 4.14
Part 1: GSK1795091 100 ng	-4.2	± 4.88

DBP, Day 1, 6 hour

Group	Value	95% CI
Part 1: Placebo	-0.5	± 4.86
Part 1: GSK1795091 7 ng	-6.0	± 4.86
Part 1: GSK1795091 21 ng	-3.5	± 6.09
Part 1: GSK1795091 60 ng	-5.3	± 8.21
Part 1: GSK1795091 Repeated 60 ng	-0.8	± 6.34
Part 1: GSK1795091 100 ng	-7.5	± 6.38

DBP, Day 1, 8 hour

Group	Value	95% CI
Part 1: Placebo	0.9	± 5.17
Part 1: GSK1795091 7 ng	-0.5	± 2.95
Part 1: GSK1795091 21 ng	-2.3	± 5.47
Part 1: GSK1795091 60 ng	-4.3	± 10.73
Part 1: GSK1795091 Repeated 60 ng	-0.8	± 5.23
Part 1: GSK1795091 100 ng	-6.8	± 6.85

DBP, Day 1, 12 hour

Group	Value	95% CI
Part 1: Placebo	-2.2	± 6.01
Part 1: GSK1795091 7 ng	-0.3	± 6.25
Part 1: GSK1795091 21 ng	-2.7	± 11.17
Part 1: GSK1795091 60 ng	-2.8	± 5.27
Part 1: GSK1795091 Repeated 60 ng	-4.3	± 7.03
Part 1: GSK1795091 100 ng	-2.0	± 8.32

DBP, Day 1, 16 hour

Group	Value	95% CI
Part 1: Placebo	-3.2	± 6.00
Part 1: GSK1795091 7 ng	-5.5	± 8.87
Part 1: GSK1795091 21 ng	-5.8	± 15.22
Part 1: GSK1795091 60 ng	-6.2	± 5.88
Part 1: GSK1795091 Repeated 60 ng	-3.8	± 5.04
Part 1: GSK1795091 100 ng	-2.7	± 10.13

DBP, Day 2

Group	Value	95% CI
Part 1: Placebo	0.0	± 5.40
Part 1: GSK1795091 7 ng	1.0	± 6.10
Part 1: GSK1795091 21 ng	-5.3	± 8.80
Part 1: GSK1795091 60 ng	-1.0	± 6.66
Part 1: GSK1795091 Repeated 60 ng	1.3	± 7.87
Part 1: GSK1795091 100 ng	0.7	± 7.00

Change From Baseline in Pulse Rate Part 1 Primary · Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.

Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.

Day 1, 1 hour

Group	Value	95% CI
Part 1: Placebo	8.1	± 6.92
Part 1: GSK1795091 7 ng	8.2	± 3.31
Part 1: GSK1795091 21 ng	11.8	± 7.65
Part 1: GSK1795091 60 ng	16.7	± 7.66
Part 1: GSK1795091 Repeated 60 ng	12.0	± 5.10
Part 1: GSK1795091 100 ng	10.2	± 4.88

Day 1, 2 hour

Group	Value	95% CI
Part 1: Placebo	5.9	± 5.36
Part 1: GSK1795091 7 ng	8.2	± 8.57
Part 1: GSK1795091 21 ng	11.3	± 11.74
Part 1: GSK1795091 60 ng	17.5	± 8.60
Part 1: GSK1795091 Repeated 60 ng	14.8	± 9.45
Part 1: GSK1795091 100 ng	14.3	± 7.45

Day 1, 4 hour

Group	Value	95% CI
Part 1: Placebo	5.0	± 7.67
Part 1: GSK1795091 7 ng	2.8	± 2.99
Part 1: GSK1795091 21 ng	11.7	± 15.12
Part 1: GSK1795091 60 ng	17.8	± 20.22
Part 1: GSK1795091 Repeated 60 ng	17.3	± 9.79
Part 1: GSK1795091 100 ng	20.8	± 5.42

Day 1, 6 hour

Group	Value	95% CI
Part 1: Placebo	8.7	± 6.73
Part 1: GSK1795091 7 ng	8.7	± 3.98
Part 1: GSK1795091 21 ng	10.8	± 13.12
Part 1: GSK1795091 60 ng	15.7	± 17.07
Part 1: GSK1795091 Repeated 60 ng	17.7	± 7.37
Part 1: GSK1795091 100 ng	15.7	± 5.09

Day 1, 8 hour

Group	Value	95% CI
Part 1: Placebo	3.2	± 6.49
Part 1: GSK1795091 7 ng	1.7	± 3.20
Part 1: GSK1795091 21 ng	4.7	± 6.15
Part 1: GSK1795091 60 ng	4.7	± 8.87
Part 1: GSK1795091 Repeated 60 ng	8.2	± 5.74
Part 1: GSK1795091 100 ng	6.3	± 5.35

Day 1, 12 hour

Group	Value	95% CI
Part 1: Placebo	4.6	± 8.45
Part 1: GSK1795091 7 ng	4.7	± 5.99
Part 1: GSK1795091 21 ng	5.2	± 15.48
Part 1: GSK1795091 60 ng	7.2	± 4.07
Part 1: GSK1795091 Repeated 60 ng	10.5	± 4.59
Part 1: GSK1795091 100 ng	9.0	± 6.57

Day 1, 16 hour

Group	Value	95% CI
Part 1: Placebo	-1.9	± 5.55
Part 1: GSK1795091 7 ng	-2.0	± 4.94
Part 1: GSK1795091 21 ng	-0.8	± 19.77
Part 1: GSK1795091 60 ng	-0.7	± 5.61
Part 1: GSK1795091 Repeated 60 ng	3.2	± 2.64
Part 1: GSK1795091 100 ng	2.8	± 5.56

Day 2

Group	Value	95% CI
Part 1: Placebo	0.3	± 4.37
Part 1: GSK1795091 7 ng	-0.3	± 3.78
Part 1: GSK1795091 21 ng	1.0	± 7.64
Part 1: GSK1795091 60 ng	4.3	± 6.12
Part 1: GSK1795091 Repeated 60 ng	0.5	± 4.04
Part 1: GSK1795091 100 ng	1.7	± 8.16

Change From Baseline in Respiratory Rate Part 1 Primary · Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.

Respiratory rate was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.

Day 1, 1 hour

Group	Value	95% CI
Part 1: Placebo	0.2	± 1.03
Part 1: GSK1795091 7 ng	1.2	± 0.41
Part 1: GSK1795091 21 ng	-0.2	± 1.17
Part 1: GSK1795091 60 ng	1.2	± 2.93
Part 1: GSK1795091 Repeated 60 ng	-0.2	± 1.60
Part 1: GSK1795091 100 ng	-0.2	± 1.94

Day 1, 2 hour

Group	Value	95% CI
Part 1: Placebo	0.3	± 1.49
Part 1: GSK1795091 7 ng	0.2	± 0.75
Part 1: GSK1795091 21 ng	-0.2	± 0.75
Part 1: GSK1795091 60 ng	1.3	± 3.08
Part 1: GSK1795091 Repeated 60 ng	1.0	± 0.89
Part 1: GSK1795091 100 ng	0.2	± 1.94

Day 1, 4 hour

Group	Value	95% CI
Part 1: Placebo	0.2	± 1.14
Part 1: GSK1795091 7 ng	0.0	± 1.79
Part 1: GSK1795091 21 ng	-0.2	± 2.93
Part 1: GSK1795091 60 ng	1.0	± 2.00
Part 1: GSK1795091 Repeated 60 ng	1.2	± 2.04
Part 1: GSK1795091 100 ng	1.5	± 4.04

Day 1, 6 hour

Group	Value	95% CI
Part 1: Placebo	0.9	± 2.96
Part 1: GSK1795091 7 ng	0.3	± 2.34
Part 1: GSK1795091 21 ng	-0.7	± 1.51
Part 1: GSK1795091 60 ng	-0.3	± 2.34
Part 1: GSK1795091 Repeated 60 ng	1.5	± 2.74
Part 1: GSK1795091 100 ng	0.7	± 3.27

Day 1, 8 hour

Group	Value	95% CI
Part 1: Placebo	1.3	± 2.31
Part 1: GSK1795091 7 ng	1.0	± 2.68
Part 1: GSK1795091 21 ng	-0.3	± 1.97
Part 1: GSK1795091 60 ng	0.8	± 4.36
Part 1: GSK1795091 Repeated 60 ng	0.8	± 1.72
Part 1: GSK1795091 100 ng	-0.5	± 2.88

Day 1, 12 hour

Group	Value	95% CI
Part 1: Placebo	0.4	± 2.37
Part 1: GSK1795091 7 ng	-0.5	± 1.76
Part 1: GSK1795091 21 ng	0.0	± 3.22
Part 1: GSK1795091 60 ng	0.8	± 2.40
Part 1: GSK1795091 Repeated 60 ng	0.8	± 1.72
Part 1: GSK1795091 100 ng	0.5	± 3.56

Day 1, 16 hour

Group	Value	95% CI
Part 1: Placebo	-0.4	± 2.22
Part 1: GSK1795091 7 ng	-1.8	± 2.14
Part 1: GSK1795091 21 ng	-1.3	± 2.25
Part 1: GSK1795091 60 ng	0.0	± 3.35
Part 1: GSK1795091 Repeated 60 ng	0.7	± 1.75
Part 1: GSK1795091 100 ng	-0.8	± 2.23

Day 2

Group	Value	95% CI
Part 1: Placebo	-0.3	± 1.70
Part 1: GSK1795091 7 ng	0.2	± 1.60
Part 1: GSK1795091 21 ng	-0.3	± 0.82
Part 1: GSK1795091 60 ng	-0.5	± 2.95
Part 1: GSK1795091 Repeated 60 ng	1.5	± 2.17
Part 1: GSK1795091 100 ng	-0.3	± 3.01

Number of Participants With Hematology Parameters Outside Reference Range Part 1 Primary · Up to Day 7

Hematology parameters included hemoglobin (HGB), hematocrit (HCT), Red Blood Cell (RBC) count, White Blood Cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), platelet count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). Reference range for basophil was 0.01 - 0.07\*10\^9/Liters (L), eosinophils 0.03 - 0.5\*10\^9/L, HCT 0.38 - 0.48 proportion of RBC in blood, HGB 126 - 165\*gram (g)/L, lymphocytes 1.08 - 3\*10\^9/L, MCH 26.3 - 32.8\*picogram (pg), MCHC 324 - 359\*g/L, MCV 77 -

Basophil, > reference range H

Group	Value	95% CI
Part 1: Placebo	0
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	0
Part 1: GSK1795091 60 ng	0
Part 1: GSK1795091 Repeated 60 ng	0
Part 1: GSK1795091 100 ng	1

Basophil, < reference range low

Group	Value	95% CI
Part 1: Placebo	1
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	0
Part 1: GSK1795091 60 ng	0
Part 1: GSK1795091 Repeated 60 ng	0
Part 1: GSK1795091 100 ng	0

Eosinophils, > reference range H

Group	Value	95% CI
Part 1: Placebo	0
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	2
Part 1: GSK1795091 60 ng	0
Part 1: GSK1795091 Repeated 60 ng	0
Part 1: GSK1795091 100 ng	1

Eosinophils, < reference range low

Group	Value	95% CI
Part 1: Placebo	2
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	0
Part 1: GSK1795091 60 ng	0
Part 1: GSK1795091 Repeated 60 ng	0
Part 1: GSK1795091 100 ng	2

MCHC, > reference range H

Group	Value	95% CI
Part 1: Placebo	1
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	0
Part 1: GSK1795091 60 ng	0
Part 1: GSK1795091 Repeated 60 ng	0
Part 1: GSK1795091 100 ng	0

MCHC,< reference range low

Group	Value	95% CI
Part 1: Placebo	0
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	1
Part 1: GSK1795091 60 ng	0
Part 1: GSK1795091 Repeated 60 ng	1
Part 1: GSK1795091 100 ng	0

MCH, > reference range H

Group	Value	95% CI
Part 1: Placebo	0
Part 1: GSK1795091 7 ng	2
Part 1: GSK1795091 21 ng	1
Part 1: GSK1795091 60 ng	0
Part 1: GSK1795091 Repeated 60 ng	1
Part 1: GSK1795091 100 ng	1

MCH, < reference range low

Group	Value	95% CI
Part 1: Placebo	0
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	1
Part 1: GSK1795091 60 ng	0
Part 1: GSK1795091 Repeated 60 ng	1
Part 1: GSK1795091 100 ng	1

Number of Participants With Clinical Chemistry Parameters Outside Reference Range Primary · Up to Day 7

Clinical chemistry parameters with reference range were albumin 35-52\*g/L, Alkaline phosphatase (ALP) 30-120\*International units/L (IU/L), Alanine aminotransferase (ALT) 0-50 \* IU/L, Aspartate aminotransferase (AST) 0-50\*IU/L, direct bilirubin 0-3.4\* micromoles/L (µmol/L), bilirubin 5-21\*µmol/L, calcium 2.2-2.65\* millimoles/L (mmol/L), cholesterol 0-5.19\* mmol/L, creatinine 59-104\* µmol/L, C-reactive protein (CRP) 0-5\*milligram (mg)/L,Gamma Glutamyl Transferase (GGT) 4.1-5.9\*mmol/L, high density lipoproteins (HDL) cholesterol 0.99-2.32\*mmol/L, potassium 3.5-5.1\*mmol/L, low density

ALT, > reference range H

Group	Value	95% CI
Part 1: Placebo	0
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	2
Part 1: GSK1795091 60 ng	0
Part 1: GSK1795091 Repeated 60 ng	1
Part 1: GSK1795091 100 ng	0

ALT, < reference range low

Group	Value	95% CI
Part 1: Placebo	0
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	0
Part 1: GSK1795091 60 ng	0
Part 1: GSK1795091 Repeated 60 ng	0
Part 1: GSK1795091 100 ng	0

Albumin, > reference range H

Group	Value	95% CI
Part 1: Placebo	00
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	0
Part 1: GSK1795091 60 ng	0
Part 1: GSK1795091 Repeated 60 ng	0
Part 1: GSK1795091 100 ng	0

Albumin, < reference range low

Group	Value	95% CI
Part 1: Placebo	0
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	0
Part 1: GSK1795091 60 ng	1
Part 1: GSK1795091 Repeated 60 ng	0
Part 1: GSK1795091 100 ng	0

ALP, > reference range H

Group	Value	95% CI
Part 1: Placebo	0
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	0
Part 1: GSK1795091 60 ng	0
Part 1: GSK1795091 Repeated 60 ng	0
Part 1: GSK1795091 100 ng	0

ALP,< reference range low

Group	Value	95% CI
Part 1: Placebo	0
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	0
Part 1: GSK1795091 60 ng	0
Part 1: GSK1795091 Repeated 60 ng	0
Part 1: GSK1795091 100 ng	0

AST, > reference range H

Group	Value	95% CI
Part 1: Placebo	0
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	0
Part 1: GSK1795091 60 ng	1
Part 1: GSK1795091 Repeated 60 ng	0
Part 1: GSK1795091 100 ng	0

AST, < reference range low

Group	Value	95% CI
Part 1: Placebo	0
Part 1: GSK1795091 7 ng	0
Part 1: GSK1795091 21 ng	0
Part 1: GSK1795091 60 ng	0
Part 1: GSK1795091 Repeated 60 ng	0
Part 1: GSK1795091 100 ng	0

Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points Primary · Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7

Urinalysis included microscopic examination parameters like Casts, REC, SEC, Urine erythrocytes and Urine leukocytes. Data at indicated time points were reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point.

Casts, Day -1 Pre-dose, n=1,0,2,1,0,1

Group	Value	95% CI
Part 1: Placebo	0.0	± NA
Part 1: GSK1795091 21 ng	0.0	± 0.0
Part 1: GSK1795091 60 ng	0.0	± NA
Part 1: GSK1795091 100 ng	0.0	± NA

Casts, Day 1, Pre-dose, n=3,1,2,0,0,2

Group	Value	95% CI
Part 1: Placebo	0.0	± 0.0
Part 1: GSK1795091 7 ng	0.0	± NA
Part 1: GSK1795091 21 ng	0.0	± 0.0
Part 1: GSK1795091 100 ng	0.0	± 0.0

Casts, Day 2, n=1,0,3,1,1,2

Group	Value	95% CI
Part 1: Placebo	0.0	± NA
Part 1: GSK1795091 21 ng	0.0	± 0.0
Part 1: GSK1795091 60 ng	0.0	± NA
Part 1: GSK1795091 Repeated 60 ng	0.0	± NA
Part 1: GSK1795091 100 ng	0.0	± 0.0

Casts, Day 4, n=3,0,1,2,0,0

Group	Value	95% CI
Part 1: Placebo	0.0	± 0.0
Part 1: GSK1795091 21 ng	0.0	± NA
Part 1: GSK1795091 60 ng	0.0	± 0.0

Casts, Day 7, n=4,0,2,2,0,0

Group	Value	95% CI
Part 1: Placebo	0.0	± 0.0
Part 1: GSK1795091 21 ng	0.0	± 0.0
Part 1: GSK1795091 60 ng	0.0	± 0.0

REC, Day -1 Pre-dose, n=1,0,2,1,0,1

Group	Value	95% CI
Part 1: Placebo	0.0	± NA
Part 1: GSK1795091 21 ng	0.0	± 0.0
Part 1: GSK1795091 60 ng	0.0	± NA
Part 1: GSK1795091 100 ng	0.0	± NA

REC, Day 1 Pre-dose, n=3,1,2,0,0,2

Group	Value	95% CI
Part 1: Placebo	0.0	± 0.0
Part 1: GSK1795091 7 ng	0.0	± NA
Part 1: GSK1795091 21 ng	0.0	± 0.0
Part 1: GSK1795091 100 ng	0.0	± 0.0

REC, Day 2 , n=1,0,3,1,1,2

Group	Value	95% CI
Part 1: Placebo	0.0	± NA
Part 1: GSK1795091 21 ng	0.0	± 0.0
Part 1: GSK1795091 60 ng	0.0	± NA
Part 1: GSK1795091 Repeated 60 ng	0.0	± NA
Part 1: GSK1795091 100 ng	0.0	± 0.0

Ketones and Urine Glucose at Indicated Time Points Primary · Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7

Urinalysis included parameters like ketones and urine glucose. Data at indicated time points were reported.

Ketones, Pre-dose Day -1

Group	Value	95% CI
Part 1: Placebo	0.05	± 0.158
Part 1: GSK1795091 7 ng	0.00	± 0.000
Part 1: GSK1795091 21 ng	0.08	± 0.204
Part 1: GSK1795091 60 ng	0.00	± 0.000
Part 1: GSK1795091 Repeated 60 ng	0.00	± 0.000
Part 1: GSK1795091 100 ng	0.25	± 0.612

Ketones, Pre-dose Day 1

Group	Value	95% CI
Part 1: Placebo	0.05	± 0.158
Part 1: GSK1795091 7 ng	0.00	± 0.000
Part 1: GSK1795091 21 ng	0.25	± 0.612
Part 1: GSK1795091 60 ng	0.00	± 0.000
Part 1: GSK1795091 Repeated 60 ng	0.00	± 0.000
Part 1: GSK1795091 100 ng	0.08	± 0.204

Ketones, Day 2

Group	Value	95% CI
Part 1: Placebo	0.00	± 0.000
Part 1: GSK1795091 7 ng	0.00	± 0.000
Part 1: GSK1795091 21 ng	0.00	± 0.00
Part 1: GSK1795091 60 ng	0.00	± 0.000
Part 1: GSK1795091 Repeated 60 ng	0.00	± 0.000
Part 1: GSK1795091 100 ng	1.75	± 2.525

Ketones, Day 4

Group	Value	95% CI
Part 1: Placebo	0.15	± 0.242
Part 1: GSK1795091 7 ng	0.00	± 0.000
Part 1: GSK1795091 21 ng	0.08	± 0.204
Part 1: GSK1795091 60 ng	0.00	± 0.000
Part 1: GSK1795091 Repeated 60 ng	0.00	± 0.000
Part 1: GSK1795091 100 ng	0.08	± 0.204

Ketones, Day 7

Group	Value	95% CI
Part 1: Placebo	0.00	± 0.000
Part 1: GSK1795091 7 ng	0.00	± 0.000
Part 1: GSK1795091 21 ng	0.08	± 0.204
Part 1: GSK1795091 60 ng	0.25	± 0.612
Part 1: GSK1795091 Repeated 60 ng	0.00	± 0.000
Part 1: GSK1795091 100 ng	0.08	± 0.204

Urine glucose, Pre-dose Day -1

Group	Value	95% CI
Part 1: Placebo	0.0	± 0.00
Part 1: GSK1795091 7 ng	0.0	± 0.00
Part 1: GSK1795091 21 ng	0.0	± 0.00
Part 1: GSK1795091 60 ng	0.0	± 0.00
Part 1: GSK1795091 Repeated 60 ng	0.0	± 0.00
Part 1: GSK1795091 100 ng	0.0	± 0.00

Urine glucose, Pre-dose Day 1

Group	Value	95% CI
Part 1: Placebo	0.0	± 0.00
Part 1: GSK1795091 7 ng	0.0	± 0.00
Part 1: GSK1795091 21 ng	0.0	± 0.00
Part 1: GSK1795091 60 ng	0.0	± 0.00
Part 1: GSK1795091 Repeated 60 ng	0.0	± 0.00
Part 1: GSK1795091 100 ng	0.0	± 0.00

Urine glucose, Day 2

Group	Value	95% CI
Part 1: Placebo	0.0	± 0.00
Part 1: GSK1795091 7 ng	0.0	± 0.00
Part 1: GSK1795091 21 ng	0.0	± 0.00
Part 1: GSK1795091 60 ng	0.0	± 0.00
Part 1: GSK1795091 Repeated 60 ng	0.0	± 0.00
Part 1: GSK1795091 100 ng	0.0	± 0.00

Occult Blood at Indicated Time Points Primary · Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7

Urinalysis included parameter like Occult blood. Data at indicated time points were reported.

Pre-dose Day -1

Group	Value	95% CI
Part 1: Placebo	2.5	± 7.91
Part 1: GSK1795091 7 ng	0.0	± 0.00
Part 1: GSK1795091 21 ng	5.8	± 10.21
Part 1: GSK1795091 60 ng	0.0	± 0.00
Part 1: GSK1795091 Repeated 60 ng	0.0	± 0.00
Part 1: GSK1795091 100 ng	0.0	± 0.00

Pre-dose Day 1

Group	Value	95% CI
Part 1: Placebo	4.5	± 8.32
Part 1: GSK1795091 7 ng	1.7	± 4.08
Part 1: GSK1795091 21 ng	3.3	± 5.16
Part 1: GSK1795091 60 ng	0.0	± 0.00
Part 1: GSK1795091 Repeated 60 ng	0.0	± 0.00
Part 1: GSK1795091 100 ng	1.7	± 4.08

Day 2

Group	Value	95% CI
Part 1: Placebo	2.5	± 7.91
Part 1: GSK1795091 7 ng	0.0	± 0.00
Part 1: GSK1795091 21 ng	5.0	± 5.48
Part 1: GSK1795091 60 ng	4.2	± 10.21
Part 1: GSK1795091 Repeated 60 ng	1.7	± 4.08
Part 1: GSK1795091 100 ng	5.8	± 10.21

Day 4

Group	Value	95% CI
Part 1: Placebo	4.5	± 8.32
Part 1: GSK1795091 7 ng	0.0	± 0.00
Part 1: GSK1795091 21 ng	0.0	± 0.00
Part 1: GSK1795091 60 ng	4.2	± 10.21
Part 1: GSK1795091 Repeated 60 ng	0.0	± 0.00
Part 1: GSK1795091 100 ng	0.0	± 0.00

Day 7

Group	Value	95% CI
Part 1: Placebo	4.0	± 5.16
Part 1: GSK1795091 7 ng	0.0	± 0.00
Part 1: GSK1795091 21 ng	8.3	± 12.91
Part 1: GSK1795091 60 ng	0.0	± 0.00
Part 1: GSK1795091 Repeated 60 ng	0.0	± 0.00
Part 1: GSK1795091 100 ng	0.0	± 0.00

Urine Protein at Indicated Time Points Primary · Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7

Urinalysis included parameter like Urine protein. Data at indicated time points were reported.

Pre-dose Day -1

Group	Value	95% CI
Part 1: Placebo	0.000	± 0.0000
Part 1: GSK1795091 7 ng	0.000	± 0.0000
Part 1: GSK1795091 21 ng	0.042	± 0.1021
Part 1: GSK1795091 60 ng	0.000	± 0.0000
Part 1: GSK1795091 Repeated 60 ng	0.000	± 0.0000
Part 1: GSK1795091 100 ng	0.000	± 0.0000

Pre-dose Day 1

Group	Value	95% CI
Part 1: Placebo	0.000	± 0.0000
Part 1: GSK1795091 7 ng	0.000	± 0.0000
Part 1: GSK1795091 21 ng	0.000	± 0.0000
Part 1: GSK1795091 60 ng	0.000	± 0.0000
Part 1: GSK1795091 Repeated 60 ng	0.000	± 0.0000
Part 1: GSK1795091 100 ng	0.000	± 0.0000

Day 2

Group	Value	95% CI
Part 1: Placebo	0.000	± 0.0000
Part 1: GSK1795091 7 ng	0.000	± 0.0000
Part 1: GSK1795091 21 ng	0.000	± 0.0000
Part 1: GSK1795091 60 ng	0.000	± 0.0000
Part 1: GSK1795091 Repeated 60 ng	0.000	± 0.0000
Part 1: GSK1795091 100 ng	0.000	± 0.0000

Day 4

Group	Value	95% CI
Part 1: Placebo	0.025	± 0.0791
Part 1: GSK1795091 7 ng	0.000	± 0.0000
Part 1: GSK1795091 21 ng	0.042	± 0.1021
Part 1: GSK1795091 60 ng	0.000	± 0.0000
Part 1: GSK1795091 Repeated 60 ng	0.000	± 0.0000
Part 1: GSK1795091 100 ng	0.000	± 0.0000

Day 7

Group	Value	95% CI
Part 1: Placebo	0.000	± 0.0000
Part 1: GSK1795091 7 ng	0.000	± 0.0000
Part 1: GSK1795091 21 ng	0.042	± 0.1021
Part 1: GSK1795091 60 ng	0.042	± 0.1021
Part 1: GSK1795091 Repeated 60 ng	0.000	± 0.0000
Part 1: GSK1795091 100 ng	0.000	± 0.0000

Specific Gravity at Indicated Time Points Primary · Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7

Urinalysis included parameter like specific gravity. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine.

Pre-dose Day -1

Group	Value	95% CI
Part 1: Placebo	1.018	± 0.0065
Part 1: GSK1795091 7 ng	1.008	± 0.0053
Part 1: GSK1795091 21 ng	1.017	± 0.0091
Part 1: GSK1795091 60 ng	1.015	± 0.0019
Part 1: GSK1795091 Repeated 60 ng	1.008	± 0.0030
Part 1: GSK1795091 100 ng	1.019	± 0.0047

Pre-dose Day 1

Group	Value	95% CI
Part 1: Placebo	1.014	± 0.0072
Part 1: GSK1795091 7 ng	1.011	± 0.0048
Part 1: GSK1795091 21 ng	1.015	± 0.0083
Part 1: GSK1795091 60 ng	1.013	± 0.0063
Part 1: GSK1795091 Repeated 60 ng	1.008	± 0.0031
Part 1: GSK1795091 100 ng	1.014	± 0.0060

Day 2

Group	Value	95% CI
Part 1: Placebo	1.017	± 0.0049
Part 1: GSK1795091 7 ng	1.013	± 0.0055
Part 1: GSK1795091 21 ng	1.017	± 0.0041
Part 1: GSK1795091 60 ng	1.016	± 0.0044
Part 1: GSK1795091 Repeated 60 ng	1.014	± 0.0048
Part 1: GSK1795091 100 ng	1.017	± 0.0072

Day 4

Group	Value	95% CI
Part 1: Placebo	1.019	± 0.0069
Part 1: GSK1795091 7 ng	1.014	± 0.0041
Part 1: GSK1795091 21 ng	1.018	± 0.0072
Part 1: GSK1795091 60 ng	1.016	± 0.0038
Part 1: GSK1795091 Repeated 60 ng	1.014	± 0.0061
Part 1: GSK1795091 100 ng	1.016	± 0.0059

Day 7

Group	Value	95% CI
Part 1: Placebo	1.016	± 0.0082
Part 1: GSK1795091 7 ng	1.006	± 0.0025
Part 1: GSK1795091 21 ng	1.015	± 0.0117
Part 1: GSK1795091 60 ng	1.015	± 0.0090
Part 1: GSK1795091 Repeated 60 ng	1.010	± 0.0079
Part 1: GSK1795091 100 ng	1.013	± 0.0058

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 102 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: Placebo

Serious: 0/10 (0%)

Deaths: 0/10

Part 1: GSK1795091 7 ng

Serious: 0/6 (0%)

Deaths: 0/6

Part 1: GSK1795091 21 ng

Serious: 0/6 (0%)

Deaths: 0/6

Part 1: GSK1795091 60 ng

Serious: 0/6 (0%)

Deaths: 0/6

Part 1: GSK1795091 Repeated 60 ng

Serious: 0/6 (0%)

Deaths: 0/6

Part 1: GSK1795091 100 ng

Serious: 0/6 (0%)

Deaths: 0/6

All Participants in Part 2

Serious: 0

Deaths: 0

Other adverse events (10 terms — click to expand)

Reaction	System	Part 1: Placebo	Part 1: GSK1795091 7 ng	Part 1: GSK1795091 21 ng	Part 1: GSK1795091 60 ng	Part 1: GSK1795091 Repeate…	Part 1: GSK1795091 100 ng	All Participants in Part 2
Influenza like illness	General disorders	—	—	—	—	—	—	—
Body temperature increased	Investigations	—	—	—	—	—	—	—
Presyncope	Nervous system disorders	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—
Heart rate increased	Investigations	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT02798978 adverse events section.

Sponsor's own description

This study is an ascending dose first-time-in-human study to determine the safety, tolerability, pharmacodynamic (PD), and pharmacokinetics (PK) profile of GSK1795091 in healthy subjects. The results will support the design of future clinical trials of GSK1795091 administered to subjects with advanced malignancies in combination with immune system modulators. Part 1 will be a randomized, double-blind (sponsor-unblinded), placebo-controlled, single center, single dose escalation, sequential group evaluation of intravenously administered GSK1795091 to evaluate the safety and tolerability in healthy subjects. Part 2 will be an open-label, parallel group evaluation of 2 doses of GSK1795091 administered, either 1 week apart (Part 2, Cohort 1) or 2 weeks apart (Part 2, Cohort 2). In Part 2, on Day 1, subjects will receive intravenous GSK1795091 at a dose determined by results from Part 1. The total duration of this study is approximately 10 weeks from screening to the last study visit.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Pattern recognition receptors in health and diseases.
Li D, Wu M. · · 2021 · cited 1148× · PMID 34344870 · DOI 10.1038/s41392-021-00687-0
Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
Role of lysosomes in physiological activities, diseases, and therapy.
Zhang Z, Yue P, Lu T, Wang Y, et al · · 2021 · cited 238× · PMID 33990205 · DOI 10.1186/s13045-021-01087-1
Recent clinical trends in Toll-like receptor targeting therapeutics.
Anwar MA, Shah M, Kim J, Choi S. · · 2019 · cited 209× · PMID 30450666 · DOI 10.1002/med.21553
Trial Watch: Toll-like receptor agonists in cancer immunotherapy.
Smith M, García-Martínez E, Pitter MR, Fucikova J, et al · · 2018 · cited 171× · PMID 30524908 · DOI 10.1080/2162402x.2018.1526250
Harnessing innate immune pathways for therapeutic advancement in cancer.
Hu A, Sun L, Lin H, Liao Y, et al · · 2024 · cited 150× · PMID 38523155 · DOI 10.1038/s41392-024-01765-9
Toll-like receptor-guided therapeutic intervention of human cancers: molecular and immunological perspectives.
Mukherjee S, Patra R, Behzadi P, Masotti A, et al · · 2023 · cited 102× · PMID 37822929 · DOI 10.3389/fimmu.2023.1244345
TLR4-Targeting Therapeutics: Structural Basis and Computer-Aided Drug Discovery Approaches.
Ain QU, Batool M, Choi S. · · 2020 · cited 84× · PMID 32023919 · DOI 10.3390/molecules25030627

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02798978 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 27 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02798978.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02798978

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of GSK1795091

Other recruiting trials for Cancer

Other GlaxoSmithKline trials

Verify against primary sources