Advanced Solid Tumors with a KRAS p.G12C Mutation
Conditions
Brief summary
Treatment-emergent AEs, treatment-related Aes, Clinically significant changes in vital signs, physical examinations, ECGs, and clinical laboratory test, The MTD, if applicable, will be based on DLTs, The RP2D in the expansion part will be based on emerging data
Detailed description
PK parameters of D3S-001 including, but not limited to: Cmax, tmax, t1/2, and AUC, PK parameters of D3S-001 including, but not limited to: Cmax, tmax, t1/2, and AUC in the fed versus. fasted states for the food effect assessment, ORR, DOR, DCR, DCR at 24 weeks (CR, PR, or SD ≥24 weeks), and PFS as assessed per RECIST v1.1 by investigators and BICR
Interventions
DRUGErbitux 5 mg/mL solution for infusion
DRUGCISPLATIN
DRUGPEMETREXED
DRUGD3S-001
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGCARBOPLATIN
Sponsors
D3 Bio (Wuxi) Co. Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-emergent AEs, treatment-related Aes, Clinically significant changes in vital signs, physical examinations, ECGs, and clinical laboratory test, The MTD, if applicable, will be based on DLTs, The RP2D in the expansion part will be based on emerging data | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters of D3S-001 including, but not limited to: Cmax, tmax, t1/2, and AUC, PK parameters of D3S-001 including, but not limited to: Cmax, tmax, t1/2, and AUC in the fed versus. fasted states for the food effect assessment, ORR, DOR, DCR, DCR at 24 weeks (CR, PR, or SD ≥24 weeks), and PFS as assessed per RECIST v1.1 by investigators and BICR | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed