An Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Participants With Solid Tumors and Non-Hodgkin's Lymphoma
CompletedPhase 1Results postedLast updated 10 March 2025
What this trial tests
Phase 1 trial testing GSK3326595 in Neoplasms in 297 participants. Completed in 30 August 2023.
18 and older, any sex, with 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.
Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)Primary· Up to 30 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are
Any AEs
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
7
Part 1: GSK3326595 300mg QD
3
Part 1: GSK3326595 400mg QD
19
Part 1: GSK3326595 600mg QD
3
Part 1: GSK3326595 50mg Twice Daily (BID)
1
Part 1: GSK3326595 100mg BID
7
Part 1: GSK3326595 150mg BID
6
Part 1: GSK3326595 200mg BID
3
Any SAEs
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
4
Part 1: GSK3326595 300mg QD
1
Part 1: GSK3326595 400mg QD
10
Part 1: GSK3326595 600mg QD
1
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
2
Part 1: GSK3326595 150mg BID
3
Part 1: GSK3326595 200mg BID
3
Part 1: Number of Participants Withdrawn Due to AEsPrimary· Up to 30 months
The data for number of participants withdrawn due to AEs have been presented.
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
2
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
2
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
0
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
1
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)Primary· Up to 21 days
DLT is considered to be clinically relevant AE by investigator if it met at least one of the criteria: Grade(G)3 neutropenia for \>=5 days/G4 neutropenia of any duration, G3 or greater febrile neutropenia, G4 or greater anemia of any duration and thrombocytopenia, or G3 thrombocytopenia with bleeding, Alanine aminotransferase (ALT) \>3x upper limit of normal (ULN)+bilirubin, \>=2xULN or ALT between 3-5 X ULN with bilirubin \< 2Xuln but with hepatitis symptoms/rash, G3 nausea/vomiting/diarrhea that does not improve within 72 hour, G4 or greater nausea/vomiting/diarrhea, G3 or greater hypertensi
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
0
Part 1: GSK3326595 300mg QD
1
Part 1: GSK3326595 400mg QD
2
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
0
Part 1: GSK3326595 150mg BID
1
Part 1: GSK3326595 200mg BID
1
Part 1: Number of Participants With Dose Modifications of GSK3326595Primary· Up to 30 months
The number of participants who experienced any dose modifications (interruptions and reductions) of GSK3326595 have been presented.
Dose interruptions
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
5
Part 1: GSK3326595 300mg QD
3
Part 1: GSK3326595 400mg QD
18
Part 1: GSK3326595 600mg QD
2
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
5
Part 1: GSK3326595 150mg BID
4
Part 1: GSK3326595 200mg BID
2
Dose reductions
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
0
Part 1: GSK3326595 300mg QD
1
Part 1: GSK3326595 400mg QD
16
Part 1: GSK3326595 600mg QD
2
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
2
Part 1: GSK3326595 150mg BID
2
Part 1: GSK3326595 200mg BID
3
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry ParametersPrimary· Baseline (Day 1) and up to 30 months
Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Alanine Aminotransferase, decreases to low
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
2
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
4
Part 1: GSK3326595 600mg QD
1
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
0
Part 1: GSK3326595 150mg BID
1
Part 1: GSK3326595 200mg BID
1
Alanine Aminotransferase, changes to normal or no changes
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
4
Part 1: GSK3326595 300mg QD
1
Part 1: GSK3326595 400mg QD
13
Part 1: GSK3326595 600mg QD
1
Part 1: GSK3326595 50mg Twice Daily (BID)
1
Part 1: GSK3326595 100mg BID
6
Part 1: GSK3326595 150mg BID
4
Part 1: GSK3326595 200mg BID
2
Alanine Aminotransferase, increases to high
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
1
Part 1: GSK3326595 300mg QD
2
Part 1: GSK3326595 400mg QD
2
Part 1: GSK3326595 600mg QD
1
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
1
Part 1: GSK3326595 150mg BID
1
Part 1: GSK3326595 200mg BID
0
Albumin, decreases to low
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
4
Part 1: GSK3326595 300mg QD
1
Part 1: GSK3326595 400mg QD
12
Part 1: GSK3326595 600mg QD
1
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
2
Part 1: GSK3326595 150mg BID
5
Part 1: GSK3326595 200mg BID
1
Albumin, changes to normal or no changes
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
3
Part 1: GSK3326595 300mg QD
2
Part 1: GSK3326595 400mg QD
7
Part 1: GSK3326595 600mg QD
2
Part 1: GSK3326595 50mg Twice Daily (BID)
1
Part 1: GSK3326595 100mg BID
5
Part 1: GSK3326595 150mg BID
1
Part 1: GSK3326595 200mg BID
2
Albumin, increases to high
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
0
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
0
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
0
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
0
Alkaline Phosphatase, decreases to low
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
0
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
0
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
0
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
0
Alkaline Phosphatase, changes to normal or no changes
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
7
Part 1: GSK3326595 300mg QD
2
Part 1: GSK3326595 400mg QD
17
Part 1: GSK3326595 600mg QD
1
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
4
Part 1: GSK3326595 150mg BID
5
Part 1: GSK3326595 200mg BID
3
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology ParametersPrimary· Baseline (Day 1) and up to 30 months
Blood samples were collected for evaluation of hematology parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Basophils, decreases to low
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
0
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
0
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
0
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
0
Basophils, changes to normal or no changes
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
6
Part 1: GSK3326595 300mg QD
2
Part 1: GSK3326595 400mg QD
19
Part 1: GSK3326595 600mg QD
3
Part 1: GSK3326595 50mg Twice Daily (BID)
1
Part 1: GSK3326595 100mg BID
7
Part 1: GSK3326595 150mg BID
6
Part 1: GSK3326595 200mg BID
2
Basophils, increases to high
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
1
Part 1: GSK3326595 300mg QD
1
Part 1: GSK3326595 400mg QD
0
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
0
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
1
Eosinophils, decreases to low
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
2
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
1
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
0
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
0
Eosinophils, changes to normal or no changes
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
5
Part 1: GSK3326595 300mg QD
3
Part 1: GSK3326595 400mg QD
16
Part 1: GSK3326595 600mg QD
3
Part 1: GSK3326595 50mg Twice Daily (BID)
1
Part 1: GSK3326595 100mg BID
6
Part 1: GSK3326595 150mg BID
6
Part 1: GSK3326595 200mg BID
0
Eosinophils, increases to high
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
0
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
2
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
1
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
3
Mean Corpuscular Hemoglobin, decreases to low
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
2
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
1
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
2
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
1
Mean Corpuscular Hemoglobin, changes to normal or no changes
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
5
Part 1: GSK3326595 300mg QD
3
Part 1: GSK3326595 400mg QD
17
Part 1: GSK3326595 600mg QD
2
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
5
Part 1: GSK3326595 150mg BID
6
Part 1: GSK3326595 200mg BID
1
Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation ParametersPrimary· Baseline (Day 1) and up to 30 months
Blood samples were collected for evaluation of coagulation parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v4.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Partial Thromboplastin Time, decreases to low
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
0
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
1
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
1
Part 1: GSK3326595 100mg BID
0
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
0
Partial Thromboplastin Time, changes to normal or no changes
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
4
Part 1: GSK3326595 300mg QD
1
Part 1: GSK3326595 400mg QD
8
Part 1: GSK3326595 600mg QD
1
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
4
Part 1: GSK3326595 150mg BID
1
Part 1: GSK3326595 200mg BID
1
Partial Thromboplastin Time, increases to high
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
3
Part 1: GSK3326595 300mg QD
1
Part 1: GSK3326595 400mg QD
6
Part 1: GSK3326595 600mg QD
2
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
1
Part 1: GSK3326595 150mg BID
3
Part 1: GSK3326595 200mg BID
1
Prothrombin Intl. Normalized Ratio, decreases to low
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
0
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
1
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
0
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
0
Prothrombin Intl. Normalized Ratio, changes to normal or no changes
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
4
Part 1: GSK3326595 300mg QD
2
Part 1: GSK3326595 400mg QD
8
Part 1: GSK3326595 600mg QD
1
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
2
Part 1: GSK3326595 150mg BID
2
Part 1: GSK3326595 200mg BID
2
Prothrombin Intl. Normalized Ratio, increases to high
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
3
Part 1: GSK3326595 300mg QD
1
Part 1: GSK3326595 400mg QD
10
Part 1: GSK3326595 600mg QD
2
Part 1: GSK3326595 50mg Twice Daily (BID)
1
Part 1: GSK3326595 100mg BID
5
Part 1: GSK3326595 150mg BID
4
Part 1: GSK3326595 200mg BID
1
Prothrombin Time, decreases to low
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
0
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
1
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
0
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
0
Prothrombin Time, changes to normal or no changes
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
3
Part 1: GSK3326595 300mg QD
3
Part 1: GSK3326595 400mg QD
9
Part 1: GSK3326595 600mg QD
1
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
4
Part 1: GSK3326595 150mg BID
3
Part 1: GSK3326595 200mg BID
3
Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis ParametersPrimary· Baseline (Day 1) and up to 30 months
Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with no change or change to negative and change to positive have been presented.
Occult Blood, No Change or Change to Negative
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
5
Part 1: GSK3326595 300mg QD
2
Part 1: GSK3326595 400mg QD
12
Part 1: GSK3326595 600mg QD
2
Part 1: GSK3326595 50mg Twice Daily (BID)
1
Part 1: GSK3326595 100mg BID
4
Part 1: GSK3326595 150mg BID
4
Part 1: GSK3326595 200mg BID
1
Occult Blood, Change to Positive
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
2
Part 1: GSK3326595 300mg QD
1
Part 1: GSK3326595 400mg QD
7
Part 1: GSK3326595 600mg QD
1
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
3
Part 1: GSK3326595 150mg BID
2
Part 1: GSK3326595 200mg BID
2
Protein, No Change or Change to Negative
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
4
Part 1: GSK3326595 300mg QD
2
Part 1: GSK3326595 400mg QD
11
Part 1: GSK3326595 600mg QD
1
Part 1: GSK3326595 50mg Twice Daily (BID)
1
Part 1: GSK3326595 100mg BID
2
Part 1: GSK3326595 150mg BID
4
Part 1: GSK3326595 200mg BID
1
Protein, Change to Positive
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
3
Part 1: GSK3326595 300mg QD
1
Part 1: GSK3326595 400mg QD
8
Part 1: GSK3326595 600mg QD
2
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
5
Part 1: GSK3326595 150mg BID
2
Part 1: GSK3326595 200mg BID
2
Ketones, No Change or Change to Negative
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
5
Part 1: GSK3326595 300mg QD
2
Part 1: GSK3326595 400mg QD
11
Part 1: GSK3326595 600mg QD
2
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
3
Part 1: GSK3326595 150mg BID
3
Part 1: GSK3326595 200mg BID
3
Ketones, Change to Positive
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
2
Part 1: GSK3326595 300mg QD
1
Part 1: GSK3326595 400mg QD
8
Part 1: GSK3326595 600mg QD
1
Part 1: GSK3326595 50mg Twice Daily (BID)
1
Part 1: GSK3326595 100mg BID
4
Part 1: GSK3326595 150mg BID
3
Part 1: GSK3326595 200mg BID
0
Glucose, No Change or Change to Negative
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
7
Part 1: GSK3326595 300mg QD
3
Part 1: GSK3326595 400mg QD
18
Part 1: GSK3326595 600mg QD
3
Part 1: GSK3326595 50mg Twice Daily (BID)
1
Part 1: GSK3326595 100mg BID
7
Part 1: GSK3326595 150mg BID
5
Part 1: GSK3326595 200mg BID
3
Glucose, Change to Positive
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
0
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
1
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
0
Part 1: GSK3326595 150mg BID
1
Part 1: GSK3326595 200mg BID
0
Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH)Primary· Baseline (Day 1) and up to week 132
Urine samples were collected from participants to assess urine pH levels.
Baseline
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
5.00
± NA
Part 1: GSK3326595 25mg QD
5.50
± NA
Part 1: GSK3326595 50mg QD
7.00
± NA
Part 1: GSK3326595 100mg QD
6.50
± NA
Part 1: GSK3326595 200mg QD
6.00
± 0.886
Part 1: GSK3326595 300mg QD
6.17
± 0.289
Part 1: GSK3326595 400mg QD
6.11
± 0.698
Part 1: GSK3326595 600mg QD
5.67
± 0.764
Part 1: GSK3326595 50mg Twice Daily (BID)
6.50
± NA
Part 1: GSK3326595 100mg BID
5.79
± 1.075
Part 1: GSK3326595 150mg BID
5.75
± 0.524
Part 1: GSK3326595 200mg BID
6.17
± 0.764
CFB to Day 8
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0.00
± NA
Part 1: GSK3326595 25mg QD
0.00
± NA
Part 1: GSK3326595 50mg QD
-1.00
± NA
Part 1: GSK3326595 100mg QD
0.50
± NA
Part 1: GSK3326595 200mg QD
0.17
± 0.516
Part 1: GSK3326595 300mg QD
-0.25
± 0.354
Part 1: GSK3326595 400mg QD
-0.28
± 0.548
Part 1: GSK3326595 600mg QD
0.83
± 0.764
Part 1: GSK3326595 50mg Twice Daily (BID)
0.50
± NA
Part 1: GSK3326595 100mg BID
-0.07
± 1.239
Part 1: GSK3326595 150mg BID
0.08
± 0.492
Part 1: GSK3326595 200mg BID
0.33
± 1.258
CFB to Day 15
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0.00
± NA
Part 1: GSK3326595 25mg QD
0.00
± NA
Part 1: GSK3326595 50mg QD
-1.00
± NA
Part 1: GSK3326595 100mg QD
0.50
± NA
Part 1: GSK3326595 200mg QD
0.21
± 0.488
Part 1: GSK3326595 300mg QD
-0.17
± 0.289
Part 1: GSK3326595 400mg QD
-0.24
± 0.731
Part 1: GSK3326595 600mg QD
0.00
± 1.000
Part 1: GSK3326595 50mg Twice Daily (BID)
0.00
± NA
Part 1: GSK3326595 100mg BID
-0.29
± 0.859
Part 1: GSK3326595 150mg BID
0.10
± 0.548
Part 1: GSK3326595 200mg BID
1.00
± NA
CFB to Week 4 Day 1
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0.00
± NA
Part 1: GSK3326595 25mg QD
0.00
± NA
Part 1: GSK3326595 50mg QD
0.00
± NA
Part 1: GSK3326595 100mg QD
0.50
± NA
Part 1: GSK3326595 200mg QD
-0.20
± 0.447
Part 1: GSK3326595 300mg QD
-0.75
± 0.354
Part 1: GSK3326595 400mg QD
-0.13
± 0.611
Part 1: GSK3326595 600mg QD
0.67
± 1.041
Part 1: GSK3326595 50mg Twice Daily (BID)
-0.50
± NA
Part 1: GSK3326595 100mg BID
-0.21
± 0.488
Part 1: GSK3326595 150mg BID
0.10
± 0.548
Part 1: GSK3326595 300mg QD (Food Effect)
-0.10
± 0.849
CFB to Week 6 Day 1
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0.00
± NA
Part 1: GSK3326595 25mg QD
0.00
± NA
Part 1: GSK3326595 50mg QD
0.00
± NA
Part 1: GSK3326595 100mg QD
0.50
± NA
Part 1: GSK3326595 200mg QD
-0.17
± 0.577
Part 1: GSK3326595 300mg QD
0.00
± 0.000
Part 1: GSK3326595 400mg QD
-0.43
± 0.799
Part 1: GSK3326595 600mg QD
0.25
± 1.061
Part 1: GSK3326595 50mg Twice Daily (BID)
-0.50
± NA
Part 1: GSK3326595 100mg BID
-0.29
± 1.035
Part 1: GSK3326595 150mg BID
-0.08
± 0.492
Part 1: GSK3326595 200mg BID
0.00
± 0.707
CFB to Week 8
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0.00
± NA
Part 1: GSK3326595 25mg QD
-0.50
± NA
Part 1: GSK3326595 100mg QD
0.50
± NA
Part 1: GSK3326595 200mg QD
-1.17
± 1.155
Part 1: GSK3326595 300mg QD
-0.75
± 0.354
Part 1: GSK3326595 400mg QD
-0.19
± 0.630
Part 1: GSK3326595 600mg QD
1.00
± 0.707
Part 1: GSK3326595 100mg BID
0.75
± 0.645
Part 1: GSK3326595 150mg BID
-0.20
± 0.274
Part 1: GSK3326595 200mg BID
0.00
± 0.000
Part 1: GSK3326595 300mg QD (Food Effect)
0.44
± 0.682
CFB to Week 12
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0.00
± NA
Part 1: GSK3326595 200mg QD
0.00
± 0.500
Part 1: GSK3326595 300mg QD
-0.50
± NA
Part 1: GSK3326595 400mg QD
-0.11
± 0.546
Part 1: GSK3326595 600mg QD
1.00
± 1.414
Part 1: GSK3326595 100mg BID
0.38
± 0.629
Part 1: GSK3326595 150mg BID
0.00
± NA
Part 1: GSK3326595 200mg BID
-0.25
± 1.061
Part 1: GSK3326595 300mg QD (Food Effect)
0.08
± 1.021
CFB to Week 16
Group
Value
95% CI
Part 1: GSK3326595 200mg QD
-0.25
± 1.061
Part 1: GSK3326595 300mg QD
0.00
± NA
Part 1: GSK3326595 400mg QD
0.14
± 0.690
Part 1: GSK3326595 600mg QD
0.50
± 1.414
Part 1: GSK3326595 100mg BID
0.33
± 0.289
Part 1: GSK3326595 150mg BID
0.00
± NA
Part 1: GSK3326595 200mg BID
0.00
± 0.000
Part 1: GSK3326595 300mg QD (Food Effect)
-0.13
± 0.250
Part 1: Changes From Baseline in Urine Specific GravityPrimary· Baseline (Day 1) and up to week 132
Urine samples were collected from participants to assess urine specific gravity.
Baseline
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1.02
± NA
Part 1: GSK3326595 25mg QD
1.03
± NA
Part 1: GSK3326595 50mg QD
1.01
± NA
Part 1: GSK3326595 100mg QD
1.02
± NA
Part 1: GSK3326595 200mg QD
1.02
± 0.008
Part 1: GSK3326595 300mg QD
1.02
± 0.006
Part 1: GSK3326595 400mg QD
1.02
± 0.007
Part 1: GSK3326595 600mg QD
1.02
± 0.004
Part 1: GSK3326595 50mg Twice Daily (BID)
1.01
± NA
Part 1: GSK3326595 100mg BID
1.02
± 0.006
Part 1: GSK3326595 150mg BID
1.03
± 0.008
Part 1: GSK3326595 200mg BID
1.02
± 0.008
CFB to Day 8
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
-0.01
± NA
Part 1: GSK3326595 25mg QD
0.00
± NA
Part 1: GSK3326595 50mg QD
0.01
± NA
Part 1: GSK3326595 100mg QD
0.01
± NA
Part 1: GSK3326595 200mg QD
0.00
± 0.010
Part 1: GSK3326595 300mg QD
0.00
± 0.004
Part 1: GSK3326595 400mg QD
0.00
± 0.007
Part 1: GSK3326595 600mg QD
0.00
± 0.010
Part 1: GSK3326595 50mg Twice Daily (BID)
0.00
± NA
Part 1: GSK3326595 100mg BID
0.00
± 0.008
Part 1: GSK3326595 150mg BID
0.00
± 0.006
Part 1: GSK3326595 200mg BID
0.00
± 0.009
CFB to Day 15
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
-0.01
± NA
Part 1: GSK3326595 25mg QD
-0.01
± NA
Part 1: GSK3326595 50mg QD
0.01
± NA
Part 1: GSK3326595 100mg QD
0.00
± NA
Part 1: GSK3326595 200mg QD
0.00
± 0.010
Part 1: GSK3326595 300mg QD
-0.01
± 0.005
Part 1: GSK3326595 400mg QD
0.00
± 0.007
Part 1: GSK3326595 600mg QD
0.00
± 0.005
Part 1: GSK3326595 50mg Twice Daily (BID)
0.01
± NA
Part 1: GSK3326595 100mg BID
0.00
± 0.010
Part 1: GSK3326595 150mg BID
0.00
± 0.004
Part 1: GSK3326595 200mg BID
0.00
CFB to Week 4 Day 1
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
-0.01
± NA
Part 1: GSK3326595 25mg QD
-0.01
± NA
Part 1: GSK3326595 50mg QD
0.00
± NA
Part 1: GSK3326595 100mg QD
0.00
± NA
Part 1: GSK3326595 200mg QD
0.00
± 0.007
Part 1: GSK3326595 300mg QD
0.00
± 0.004
Part 1: GSK3326595 400mg QD
0.00
± 0.008
Part 1: GSK3326595 600mg QD
0.00
± 0.002
Part 1: GSK3326595 50mg Twice Daily (BID)
0.01
± NA
Part 1: GSK3326595 100mg BID
0.00
± 0.007
Part 1: GSK3326595 150mg BID
0.00
± 0.007
Part 1: GSK3326595 300mg QD (Food Effect)
0.00
± 0.007
CFB to Week 6 Day 1
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
-0.01
± NA
Part 1: GSK3326595 25mg QD
-0.01
± NA
Part 1: GSK3326595 50mg QD
0.01
± NA
Part 1: GSK3326595 100mg QD
0.01
± NA
Part 1: GSK3326595 200mg QD
0.00
± 0.008
Part 1: GSK3326595 300mg QD
-0.01
± 0.004
Part 1: GSK3326595 400mg QD
0.00
± 0.010
Part 1: GSK3326595 600mg QD
0.00
± 0.006
Part 1: GSK3326595 50mg Twice Daily (BID)
0.01
± NA
Part 1: GSK3326595 100mg BID
0.00
± 0.012
Part 1: GSK3326595 150mg BID
0.00
± 0.004
Part 1: GSK3326595 200mg BID
-0.01
± 0.007
CFB to Week 8
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
-0.01
± NA
Part 1: GSK3326595 25mg QD
0.00
± NA
Part 1: GSK3326595 100mg QD
0.01
± NA
Part 1: GSK3326595 200mg QD
0.00
± 0.008
Part 1: GSK3326595 300mg QD
-0.01
± 0.004
Part 1: GSK3326595 400mg QD
0.00
± 0.008
Part 1: GSK3326595 600mg QD
0.00
± 0.006
Part 1: GSK3326595 100mg BID
0.00
± 0.006
Part 1: GSK3326595 150mg BID
0.00
± 0.004
Part 1: GSK3326595 200mg BID
-0.01
± 0.007
Part 1: GSK3326595 300mg QD (Food Effect)
0.00
± 0.007
CFB to Week 12
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
-0.01
± NA
Part 1: GSK3326595 200mg QD
0.00
± 0.005
Part 1: GSK3326595 300mg QD
-0.01
Part 1: GSK3326595 400mg QD
0.00
± 0.008
Part 1: GSK3326595 600mg QD
-0.01
± 0.008
Part 1: GSK3326595 100mg BID
0.00
± 0.010
Part 1: GSK3326595 150mg BID
-0.01
± NA
Part 1: GSK3326595 200mg BID
-0.01
± 0.004
Part 1: GSK3326595 300mg QD (Food Effect)
0.00
± 0.006
CFB to Week 16
Group
Value
95% CI
Part 1: GSK3326595 200mg QD
0.00
± 0.011
Part 1: GSK3326595 300mg QD
-0.02
± NA
Part 1: GSK3326595 400mg QD
0.00
± 0.006
Part 1: GSK3326595 600mg QD
-0.01
± 0.004
Part 1: GSK3326595 100mg BID
-0.01
± 0.008
Part 1: GSK3326595 150mg BID
0.00
± NA
Part 1: GSK3326595 200mg BID
0.00
± 0.004
Part 1: GSK3326595 300mg QD (Food Effect)
0.00
± 0.004
Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital SignsPrimary· Baseline (Day 1) and up to 30 months
The abnormal vital sign ranges are: Heart Rate:- Low (\<60 beats per minute (bpm)), Normal (\>=60 bpm to \<=100 bpm), High (\>100 bpm); Temperature:- Low (\<=35 degree Celsius (°C)), Normal (\>35 °C and \<38 °C), High (\>=38 °C); Systolic Blood Pressure:- Low (\<90 millimeter of mercury (mmHg)), Normal (\>=90 mmHg to \<120 mmHg), High (\>=120 mmHg); Diastolic Blood Pressure:- Low (\<60 mmHg), Normal (\>=60 mmHg to \<80 mmHg), High (\>=80 mmHg). Participants were counted in the worst-case category and their value changes to (low, normal or high), unless there is no change in their category. Par
Heart Rate, changes to low
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
1
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
2
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
1
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
0
Heart Rate, changes to normal or no changes
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
5
Part 1: GSK3326595 300mg QD
3
Part 1: GSK3326595 400mg QD
12
Part 1: GSK3326595 600mg QD
3
Part 1: GSK3326595 50mg Twice Daily (BID)
1
Part 1: GSK3326595 100mg BID
3
Part 1: GSK3326595 150mg BID
6
Part 1: GSK3326595 200mg BID
2
Heart Rate, changes to high
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
1
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
6
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
3
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
1
Temperature, changes to low
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
0
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
0
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
0
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
0
Temperature, changes to normal or no changes
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
1
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
6
Part 1: GSK3326595 300mg QD
3
Part 1: GSK3326595 400mg QD
17
Part 1: GSK3326595 600mg QD
3
Part 1: GSK3326595 50mg Twice Daily (BID)
1
Part 1: GSK3326595 100mg BID
6
Part 1: GSK3326595 150mg BID
6
Part 1: GSK3326595 200mg BID
3
Temperature, changes to high
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
1
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
2
Part 1: GSK3326595 600mg QD
0
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
1
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
0
Systolic Blood Pressure, changes to low
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
0
Part 1: GSK3326595 50mg QD
0
Part 1: GSK3326595 100mg QD
0
Part 1: GSK3326595 200mg QD
0
Part 1: GSK3326595 300mg QD
0
Part 1: GSK3326595 400mg QD
3
Part 1: GSK3326595 600mg QD
1
Part 1: GSK3326595 50mg Twice Daily (BID)
0
Part 1: GSK3326595 100mg BID
1
Part 1: GSK3326595 150mg BID
0
Part 1: GSK3326595 200mg BID
0
Systolic Blood Pressure, changes to normal or no changes
Group
Value
95% CI
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
0
Part 1: GSK3326595 25mg QD
1
Part 1: GSK3326595 50mg QD
1
Part 1: GSK3326595 100mg QD
1
Part 1: GSK3326595 200mg QD
5
Part 1: GSK3326595 300mg QD
2
Part 1: GSK3326595 400mg QD
9
Part 1: GSK3326595 600mg QD
1
Part 1: GSK3326595 50mg Twice Daily (BID)
1
Part 1: GSK3326595 100mg BID
5
Part 1: GSK3326595 150mg BID
5
Part 1: GSK3326595 200mg BID
1
Part 3: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)Primary· Up to 10 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or was a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are
Any AEs
Group
Value
95% CI
Part 3: GSK3326595 100mg + Pembrolizumab 200mg
9
Any SAEs
Group
Value
95% CI
Part 3: GSK3326595 100mg + Pembrolizumab 200mg
5
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 30 months for part 1, 42 months for part 2 and 10 months for part 3..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD)
This first time in human (FTIH) open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and non-Hodgkin's lymphoma (NHL).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04676516 — A Phase II Window of Opportunity Trial of PRMT5 Inhibitor, GSK3326595, in Early Stage Breast Cancer
· Phase 2
· completed
NCT03614728 — Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (
· Phase 1, PHASE2
· terminated
Other recruiting trials for Neoplasms
Currently open trials in the same condition.
NCT07438782 — First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combinatio
· Phase 1
· recruiting
NCT07382817 — Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms
· Phase 1
· recruiting
NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum
· Phase 1
· recruiting
NCT07213609 — A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer
· Phase 1, PHASE2
· recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam
· Phase 2, PHASE3
· not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose
· Phase 1
· not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH
· Phase 3
· not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E
· Phase 3
· not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 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: 10 March 2025
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/NCT02783300.