Locally advanced unresectable or metastatic, microsatellite instability high (MSI-H) or dMMR CRC
Conditions
Brief summary
For Phase IIa: ORR assessed by standard RECIST v 1.1 criteria For Phase II b (Cohorts C and D): ORR assessed by standard RECIST v 1.1 criteria
Detailed description
For Phase IIa Safety and tolerability: AEs as characterized by type, severity (graded by the NCI CTCAE v.5.0), timing, seriousness, and relationship to study treatments. Efficacy assessed by standard RECIST v1.1 criteria: BOR,DoR, and PFS at 6, 12, 18, and 24 months. For Phase IIb (Cohorts C and D) Safety and tolerability: AEs as characterized by type, severity (graded by the NCI CTCAE v.5.0), timing, seriousness, and relationship to study treatments. Efficacy assessed by standard RECIST v
Interventions
DRUGGAd20-209-FSP
DRUGMVA-209-FSP
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Nouscom S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For Phase IIa: ORR assessed by standard RECIST v 1.1 criteria For Phase II b (Cohorts C and D): ORR assessed by standard RECIST v 1.1 criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| For Phase IIa Safety and tolerability: AEs as characterized by type, severity (graded by the NCI CTCAE v.5.0), timing, seriousness, and relationship to study treatments. Efficacy assessed by standard RECIST v1.1 criteria: BOR,DoR, and PFS at 6, 12, 18, and 24 months. For Phase IIb (Cohorts C and D) Safety and tolerability: AEs as characterized by type, severity (graded by the NCI CTCAE v.5.0), timing, seriousness, and relationship to study treatments. Efficacy assessed by standard RECIST v | — |
Countries
Belgium, Italy, Spain
Outcome results
None listed