Study Summary
This trial will test the safety and effectiveness of a new drug, GSK3745417, for treating cancer. The trial will have two parts, each testing different ways of administering the drug.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
10 Primary · 32 Secondary · Reporting Duration: Up to 2 years
Week 1
2A: AUC following administration of GSK3745417 in combination with pembrolizumab
2A: Cmax following administration of GSK3745417 in combination with pembrolizumab
2A: GSK3745417 concentrations in plasma following administration of GSK3745417 in combination with pembrolizumab
2A: t½ following administration of GSK3745417 in combination with pembrolizumab
2B: AUC following administration of GSK3745417 in combination with pembrolizumab
2B: Cmax following administration of GSK3745417 in combination with pembrolizumab
2B: GSK3745417 concentrations in plasma following administration of GSK3745417 in combination with pembrolizumab
2B: t½ following administration of GSK3745417 in combination with pembrolizumab
Week 1
1A: Apparent terminal phase half-life (t½) following administration of GSK3745417 alone
1A: Area under the concentration-time curve (AUC) following administration of GSK3745417 alone
1A: GSK3745417 concentrations in plasma following administration of GSK3745417 alone
1A: Maximum observed concentration (Cmax) following administration of GSK3745417 alone
1B: AUC following administration of GSK3745417 alone
1B: Cmax following administration of GSK3745417 alone
1B: GSK3745417 concentrations in plasma following administration of GSK3745417 alone
1B: t½ following administration of GSK3745417 alone
Up to 2 years
1A: Best objective response based on RECIST 1.1 criteria
1A: Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
1A: Severity of AEs
1B: Number of subjects with AEs and SAEs
1B: Objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
1B: Severity of AEs
2A: Best objective response based on RECIST 1.1 criteria
2A: Number of subjects with AEs and SAEs
2A: Severity of AEs
2B: 2B: Number of subjects with AEs and SAEs
2B: Objective response rate based on RECIST 1.1 criteria
2B: Severity of AEs
Parts 1A and 2A: Number of participants with adverse events (AEs) and serious adverse events (SAEs) by severity
Up to Day 21
1A: Number of subjects achieving Dose-limiting toxicity (DLT)
1B: Number of subjects achieving DLT
Up to Day 29
2A: Number of subjects achieving DLT
2B: Number of subjects achieving DLT
Parts 1A and 2A: Number of participants achieving dose-limiting toxicity (DLT)
Up to Week 104
Part 1A: Apparent terminal phase half-life (t1/2) following administration of GSK3745417 alone
Part 1A: Area under the concentration-time curve (AUC) following administration of GSK3745417 alone
Part 1A: GSK3745417 concentrations in plasma following administration of GSK3745417 alone
Part 1A: Maximum observed concentration (Cmax) following administration of GSK3745417 alone
Part 2A: AUC following administration of GSK3745417 in combination with dostarlimab
Part 2A: Cmax following administration of GSK3745417 in combination with dostarlimab
Part 2A: GSK3745417 concentrations in plasma following administration of GSK3745417 in combination with dostarlimab
Part 2A: T1/2 following administration of GSK3745417 in combination with dostarlimab
Trial Safety
Safety Progress
Side Effects for
Arm A (Phased Pembrolizumab Regimen)
71%Fatigue
43%Peripheral sensory neuropathy
38%Alopecia
38%Headache
33%Nausea
29%Dyspnea
29%Cough
29%Hypothyroidism
29%Pain
24%Rash maculo-papular
24%Constipation
19%Diarrhea
19%Pain in extremity
19%Abdominal pain
19%Infusion related reaction
19%Bloating
19%Dyspepsia
19%Anorexia
14%Allergic rhinitis
14%Dehydration
14%Anemia
14%Sinusitis
14%Nasal congestion
14%Hyperglycemia
14%Edema limbs
14%Hypokalemia
10%Neutrophil count decreased
10%Hyperthyroidism
10%Fall
10%Restlessness
10%Pneumonitis
10%Pruritus
10%Lymphedema
10%Hoarseness
10%Dry mouth
10%Myalgia
10%Hot flashes
10%Thromboembolic event
10%Mucositis oral
10%Skin infection
10%Vomiting
10%Localized edema
10%Alanine aminotransferase increased
10%Chills
10%Aspartate aminotransferase increased
10%Back pain
10%Dizziness
10%Flushing
5%Urinary tract pain
5%Atrial flutter
5%Hepatobiliary disorders - Other, specify
5%Bruising
5%Hypophosphatemia
5%Urinary urgency
5%Postnasal drip
5%Sneezing
5%Skin hyperpigmentation
5%Hypertension
5%Hypoglycemia
5%Mucosal infection
5%Alkaline phosphatase increased
5%Respiratory failure
5%Fever
5%Malaise
5%Nail infection
5%Upper respiratory infection
5%Urinary incontinence
5%Epistaxis
5%Laryngeal hemorrhage
5%Sore throat
5%Urinary frequency
5%Hepatic failure
5%Lung infection
5%Dysgeusia
5%Recurrent laryngeal nerve palsy
5%Syncope
5%Insomnia
5%Hypoxia
5%Periorbital edema
5%Hypotension
5%Metabolism and nutrition disorders - Other, specify
5%Infections and infestations - Other, specify
5%Lymph gland infection
5%Hyponatremia
5%Gastrointestinal disorders - Other
5%Urinary tract infection
5%Blood bilirubin increased
5%Creatinine increased
5%Platelet count decreased
5%Bone pain
5%Conjunctivitis
5%Eye disorders - Other, specify
5%Flashing lights
5%Non-cardiac chest pain
5%Allergic reaction
5%Hypocalcemia
5%Hypomagnesemia
5%Nail loss
5%Nail ridging
Trial Design
2 Treatment Groups
Part 2A: Participants receiving GSK3745417 + dostarlimab, Dose escalation Cohort
1 of 2
Part 1A: Participants receiving GSK3745417, Dose-escalation Cohort
1 of 2
Experimental Treatment
300 Total Participants · 2 Treatment Groups
Primary Treatment: GSK3745417 · No Placebo Group · Phase 1
Part 2A: Participants receiving GSK3745417 + dostarlimab, Dose escalation CohortExperimental Group · 2 Interventions: Dostarlimab, GSK3745417 · Intervention Types: Drug, Drug
Part 1A: Participants receiving GSK3745417, Dose-escalation Cohort
Drug
Experimental Group · 1 Intervention: GSK3745417 · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dostarlimab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,661 Previous Clinical Trials
7,950,055 Total Patients Enrolled
4 Trials studying Tumors
369 Patients Enrolled for Tumors
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,568 Previous Clinical Trials
6,134,021 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a solid tumor that has come back or has not responded to other treatments that have been proven effective.
Both men and women can participate.
Frequently Asked Questions
Are individuals currently being enrolled in this experiment?
"Confirmatively, this research is currently recruiting patients. The posting was first seen on March 12th 2019 and the last update was November 21st 2022." - Anonymous Online Contributor
Unverified Answer
Could you summarize any additional investigations that have been conducted surrounding GSK3745417?
"GSK3745417, which was initially examined in 2010 by City of Hope, has already seen 179 trials finished. Currently there are 40 more studies being conducted out of Houston, Texas." - Anonymous Online Contributor
Unverified Answer
What is the population volume of this research experiment?
"Affirmative. Information found on clinicaltrials.gov indicates that this medical trial is still recruiting participants; the study was first published in March 12th 2019 and recently amended on November 21st 2022. 300 patients need to be recruited at 3 distinct locations." - Anonymous Online Contributor
Unverified Answer
Has the Food and Drug Administration given its seal of approval to GSK3745417?
"As this trial is in its early stages, the safety of GSK3745417 was assigned a score 1. This means that while efficacy has been preliminarily established, there are limited data points verifying safety." - Anonymous Online Contributor
Unverified Answer