| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03843359 | A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 97 | — | — | Mar 12, 2019 | Mar 31, 2026 | Jan 8, 2026 | 13 | United States, Australia +6 |
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
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
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
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
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Part 1A: Participants receiving GSK3745417, Dose-escalation Cohort | EXPERIMENTAL | - |
| Part 2A: Participants receiving GSK3745417 + dostarlimab, Dose escalation Cohort | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GSK3745417 | DRUG | GSK3745417 will be administered. |
| Dostarlimab | DRUG | Dostarlimab will be administered. |
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 cytologi...