Stopped: No clear benefit of GB1275 was observed either as monotherapy or in combination with pembrolizumab.
This first-in-human (FIH ) study is an open-label, multicenter study that consists of a Phase 1 Dose Escalation/Expansion phase of GB1275 monotherapy or in combination with Anti-PD-1 Antibody or in combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma followed by a Phase 2 Basket Expansion phase in Patients with Specified Metastatic Solid Tumors
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Phase 1 Dose Escalation - Regimens A, B,and C: Incidence of dose limiting toxicities (DLTs)
Timeframe: Regimen A and B dose escalation Days 1-21, Regimen C dose escalation Days 8-36 days
Phase 1 Dose Escalation - Regimens A, B, and C and Phase 1 Expansion - Regimen B: Incidence of adverse events (AEs)
Timeframe: Regimen A and C from first dose through 30 days post last dose, Regimen B from first dose through 90 days post last dose
Phase 1 Dose Escalation - Regimens A and B: Cmax of GB1275
Timeframe: From first dose through 30 days post last dose
Phase 1 Dose Escalation - Regimens A and B: Ctrough of GB1275
Timeframe: From first dose through 30 days post last dose
Phase 1 Dose Escalation - Regimens A and B: Tmax of GB1275
Timeframe: From first dose through 30 days post last dose
Phase 1 Dose Escalation - Regimens A and B: t1/2 of GB1275
Timeframe: From first dose through 30 days post last dose
Phase 1 Dose Escalation - Regimens A and B: AUC of GB1275
Timeframe: From first dose through 30 days post last dose
Phase 1 Dose Escalation - Regimens A and B: CL/F of GB1275
Timeframe: From first dose through 30 days post last dose
Phase 2 - Basket Cohorts 1, 2 and 3: Objective Response Rate (ORR)
Timeframe: 24 months