A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors

A Phase I First Time in Human Open Label Study of GSK3745417 Administered With and Without Anticancer Agents in Participants With Advanced Solid Tumors

This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone (Part 1A) or co-administered (Part 2A) with dostarlimab in participants with refractory/relapsed solid tumors. Both parts will consist of a dose escalation phase.

Study Overview

• Status: Active, not recruiting
• Conditions: Neoplasms
• Intervention / Treatment: Drug: Dostarlimab; Drug: GSK3745417

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • GSK Investigational Site
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1Z9
      • GSK Investigational Site
• France
  • Bordeaux, France, 33076
    • GSK Investigational Site
  • Villejuif, France, 94805
    • GSK Investigational Site
• Japan
  • Tokyo, Japan, 104-0045
    • GSK Investigational Site
  • Tokyo, Japan, 135-8550
    • GSK Investigational Site
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • GSK Investigational Site
  • Amsterdam, Netherlands, 1066 CX
    • GSK Investigational Site
• South Korea
  • Seoul, South Korea, 03080
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Madrid, Spain, 28050
    • GSK Investigational Site
• United States
  • Texas
    • Houston, Texas, United States, 77030
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant must be more than or equal to (>=)18 years of age.
• Participants with advanced/recurrent solid tumors, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established.
• Histological or cytological documentation of an advanced solid tumor.
• Participants must provide a fresh biopsy.
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
• Adequate organ function per protocol specifications.
• Male or female participants.
• Female participants are eligible to participate if they are not breastfeeding or pregnant (or intend to breastfeed or become pregnant). Women of childbearing potential must use a highly effective method of contraception.
• Capable of giving signed informed consent.

Exclusion Criteria:

• Active autoimmune disease that has required systemic disease modifying or immunosuppressive treatment within the last 2 years.
• Concurrent medical condition requiring the use of systemic immunosuppressive treatment within 28 days before the first dose of study treatment.
• Current unstable liver or biliary disease.
• History of vasculitis at any time prior to study treatment.
• Evidence or history of significant active bleeding or coagulation disorder.
• Active infection requiring systemic treatment, known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C.
• QT duration corrected for heart rate by Fridericia's formula (QTcF) more than (>)450 milliseconds (msec) or QTcF >480 msec for participants with bundle branch block.
• Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.
• Recent history of allergen desensitization therapy within 4 weeks of starting study treatment.
• History or evidence of cardiovascular (CV) risk
• Recent (within the past 6 months) history of symptomatic pericarditis.
• History of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis.
• History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
• Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.

• Prior treatment with the following agents:

  1. Stimulator of Interferon Genes (STING) agonist at any time.
  2. Anticancer therapy or investigational therapy or used an investigational device within 28 days or 5 half-lives of the drug, whichever is shorter.
  3. Checkpoint inhibitors, including Programmed death receptor-1 (PD-1), Programmed death Ligand-1 (PD-L1), PD-L2 and Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors within 28 days.
  4. Prior radiation therapy: permissible if at least 1 non-irradiated measurable lesion is available for assessment according to RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented.
• Pregnant and/or breast feeding participants or those who plan to become pregnant and/or breastfeed.
• Receipt of any live vaccine within 30 days of the start of study treatment.
• Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
• Major surgery less than or equal to (<=)28 days before the first dose of study treatment. Participants must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment.
• Participants with signs/symptoms suggestive of Coronavirus Disease-2019 (COVID-19) within 14 days of study entry, or with known exposure to COVID-19 within 14 days prior to study entry.
• Participants are excluded from Part 2A of the study if they have known hypersensitivity to dostarlimab or associated excipients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1A: Participants receiving GSK3745417, Dose-escalation Cohort	Drug: GSK3745417; GSK3745417 will be administered.
Experimental: Part 2A: Participants receiving GSK3745417 + dostarlimab, Dose escalation Cohort	Drug: Dostarlimab; Dostarlimab will be administered.; Drug: GSK3745417; GSK3745417 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W)	AE is DLT if deemed clinically relevant,attributed to study intervention & met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0	Up to 21 Days
Parts 1A: Number of Participants Achieving DLT Following Administration of GSK3745417 Alone (Q3W)	AE is DLT if deemed clinically relevant,attributed to study intervention & met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0	Up to 29 Days
Parts 2A: Number of Participants Achieving DLT Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)	AE is DLT if deemed clinically relevant,attributed to study intervention & met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0	Up to 29 Days
Parts 2A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)	AE is DLT if deemed clinically relevant,attributed to study intervention & met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0	Up to 29 Days
Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity	AE is any untoward medical occurrence in clinical investigation participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to National Cancer Institute Common Terminology Criteria for AE (NCI-CTCAE) (version 5.0):G1=Mild,G2=Moderate,G3=Severe or medically significant but not immediately life-threatening,G4=Life-threatening consequences,G5=Death related AE.	Up to approximately 62 weeks
Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity	AE is any untoward medical occurrence in clinical investigation participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to NCI-CTCAE v5.0: G1=Mild, G2=Moderate, G3=Severe or medically significant but not immediately life-threatening, G4=Life-threatening consequences, G5=Death related AE.	Up to approximately 93 weeks
Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity	AE is any untoward medical occurrence in clinical investigation participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to NCI-CTCAE v5.0: G1=Mild, G2=Moderate, G3=Severe or medically significant but not immediately life-threatening, G4=Life-threatening consequences, G5=Death related AE.	Up to 30.3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.	Pre-dose on weeks(W) 1-6,9,10,12,19,55;end of infusion(EOI)+5minute(min) on W 1-6, 9,10,12,19,55;EOI+4 hour(HR)/8 HR on W 1-6, 9, 10, 12, 19;EOI+15min/30min/45min/1HR on W 1-6, 9,12;EOI+24HR on W 1-6, 9,10,12; EOI+2HR on W 1-6,9,10,12,19,55
Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.	Week 1 to 6, 9, 10, 12, 19
Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.	Week 1 to 6, 9, 10, 12, 19
Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.	Week 1 to 6, 9, 10, 12, 19
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.	Pre-dose on W 1, 4, 7, 10, 13, 16, 19; EOI+5min/ 15min/ 30 min/ 45 min/1HR/ 2HR/ 4HR on W 1, 4, 7, 10, 13, 16, 19; EOI+8HR/ 24HR on W 1, 4, 7, 10, 13, 16
Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.	Week 1, 4, 7, 10, 13, 16, 19
Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.	Week 1, 4, 7, 10, 13, 16, 19
Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.	Week 1, 4, 7, 10, 13, 16, 19
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Pre-dose,EOI+5min/2HR/4HR on W 1 to 5, 7, 10, 13, 19, 37, 55; EOI+15min/ 30min/ 45 min/ 1HR on W 1, 4, 7; EOI+8HR on W 1 to 5, 7, 10, 13, 19; EOI+24HR on W 1 to 5, 7, 10
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Week 1 to 5, 7, 10, 13, 19
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Week 1 to 5, 7, 10, 13, 19
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Week 1 to 5, 7, 10, 13, 19
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Pre-dose and EOI+5min/ 2HR/ 4HR on W 1, 2, 5, 6, 8, 11, 14, 20, 38; EOI+15min/ 30min/ 45min/ 1HR/ 6HR on W 1 and 8; EOI+8HR in W 1, 2, 5, 6, 8; EOI+24HR on W 1, 2, 5, 8.
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Week 1, 2, 5, 6, 8
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Week 1, 2, 5, 6, 8
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Week 1, 2, 5, 6, 8
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Pre-dose on W 1, 4, 7, 10, 13, 19, 37, 55, 73, 91; EOI+5min/ 4HR on W 1, 4, 7, 10, 13, 19, 37, 55, 91; EOI+15min/ 30min/ 45min/ 1HR/ 6HR on W 1, 4, 7; EOI+2HR on W 1, 4, 7, 10, 13, 19, 37, 55, 73; EOI+8HR/24 HR on W 1, 4, 7, 10, 13, 19, 91
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Week 1, 4, 7, 10, 13, 19, 91
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Week 1, 4, 7, 10, 13, 19, 91
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Week 1, 4, 7, 10, 13, 19, 91
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Pre-dose and EOI+5min/2HR/ 4HR/ 8HR on crossover W 1, 4, 7, 10, 13, 19; EOI+12HR/18HR on crossover W 4; EOI+15min/ 30 min/45 min/1HR/6HR/24HR on crossover W 1, 4, 7
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Crossover Week 1, 4, 7, 10, 13, 19
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Crossover Week 1, 4, 7, 10, 13, 19
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Crossover Week 1, 4, 7, 10, 13, 19
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Pre-dose and EOI+5min/ 2HR/4HR on crossover W 1-4, 7,10,19; EOI+15min/30 min/45 min/1HR/ 6HR/ 24HR on crossover W 1,4,7;EOI+12HR/18HR on crossover W 4;EOI+8HR on crossover W 1-4,7,10
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Crossover Week 1, 2, 3, 4, 5, 7, 10
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Crossover Week 1, 2, 3, 4, 5, 7, 10
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.	Crossover Week 1, 2, 3, 4, 5, 7, 10

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2019
• Primary Completion (Actual): April 4, 2024
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Monoclonal antibody; Solid tumor; First time in human; Dostarlimab; GSK3745417; Anti-Programmed death receptor-1 (PD-1); Stimulator of Interferon Genes; STING
• Additional Relevant MeSH Terms: Wounds and Injuries; Chemically-Induced Disorders; Poisoning; Neoplasms; Bites and Stings; Antineoplastic Agents; dostarlimab
• Other Study ID Numbers: 208850

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No