Advanced KRAS G12D-Mutant Solid Tumors
Conditions
Brief summary
Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, and DLTs; and abnormal vital signs, physical examination, ECG parameters, ECOG PS, clinical laboratory results; and dose interruptions/reductions., Proportion/number of participants with DLTs during the DLT assessment period (C1D1 through C1D21)., Confirmed ORR by blinded independent central review (BICR) per RECIST v1.1., Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, and DLTs; and abnormal vital signs, physical examination, ECG parameters, ECOG PS, clinical laboratory results; and dose interruptions/reductions., Proportion/number of participants with DLTs during the DLT assessment period (through C1)., Confirmed ORRby BICR, per RECIST v1.1., AUC0-t, AUC0-inf, and Cmax of midazolam, repaglinide and relative metabolites., Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs; and abnormal vital signs, physical examination, ECG parameters, ECOG PS, clinical laboratory results; and dose interruptions/reductions.
Detailed description
PK parameters derived from plasma concentrations of VS-7375 including Cmax and AUC., Confirmed ORR, DCR, and DOR per RECIST v1.1. Unless otherwise specified, all tumor response-based endpoints will be analyzed using both BICR and Investigator assessments., Confirmed ORR by Investigator-assessed DOR, BoR, DCR, PFS per RECIST 1.1 and OS., Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, and abnormal vital signs, physical examination, ECG parameters, ECOG PS, clinical laboratory results; and dose interruptions/reductions., PK parameters derived from plasma concentrations of VS-7375 including Cmax and AUC, Change in nab-paclitaxel exposures in the presence and absence of VS-7375.
Interventions
DRUGVS-7375/GFH375
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.
DRUGErbitux 5 mg/mL solution for infusion
DRUGsolution à diluer pour perfusion
DRUGCarboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DRUGAbraxane 5 mg/ml powder for dispersion for infusion.
Sponsors
Verastem Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, and DLTs; and abnormal vital signs, physical examination, ECG parameters, ECOG PS, clinical laboratory results; and dose interruptions/reductions., Proportion/number of participants with DLTs during the DLT assessment period (C1D1 through C1D21)., Confirmed ORR by blinded independent central review (BICR) per RECIST v1.1., Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, and DLTs; and abnormal vital signs, physical examination, ECG parameters, ECOG PS, clinical laboratory results; and dose interruptions/reductions., Proportion/number of participants with DLTs during the DLT assessment period (through C1)., Confirmed ORRby BICR, per RECIST v1.1., AUC0-t, AUC0-inf, and Cmax of midazolam, repaglinide and relative metabolites., Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs; and abnormal vital signs, physical examination, ECG parameters, ECOG PS, clinical laboratory results; and dose interruption | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters derived from plasma concentrations of VS-7375 including Cmax and AUC., Confirmed ORR, DCR, and DOR per RECIST v1.1. Unless otherwise specified, all tumor response-based endpoints will be analyzed using both BICR and Investigator assessments., Confirmed ORR by Investigator-assessed DOR, BoR, DCR, PFS per RECIST 1.1 and OS., Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, and abnormal vital signs, physical examination, ECG parameters, ECOG PS, clinical laboratory results; and dose interruptions/reductions., PK parameters derived from plasma concentrations of VS-7375 including Cmax and AUC, Change in nab-paclitaxel exposures in the presence and absence of VS-7375. | — |
Outcome results
None listed