metastatic colorectal cancer
Conditions
Brief summary
Dose escalation: Incidence of DLTs (dose-limiting toxicities)., Expansion cohort: ORR by Investigator, defined as the proportion of participants who have achieved a confirmed BOR of CR or PR per RECIST version 1.1.
Detailed description
Escalation: Incidence and severity of AEs graded according to the NCI CTCAE v5.0 and changes in clinical laboratory parameters, vital signs and ECGs. Incidence of dose interruptions, dose modifications and discontinuations due to AEs., Escalation: ORR, DOR, PFS, DCR and TTR by Investigator., Escalation: Plasma PK parameters of ZN-c3 (and its potential metabolites as applicable), including but not limited to Cmax, Tmax, and AUC., Escalation: Plasma PK parameters of encorafenib including but not limited to Cmax, Tmax, and AUC., Expansion: DOR, PFS, DCR and TTR by Investigator., Expansion: Incidence and severity of AEs graded according to the NCI CTCAE v5.0 and changes in clinical laboratory parameters, vital signs and ECGs. Incidence of dosing interruptions, dose modifications and discontinuations associated with AEs., Expansion: Plasma PK parameters of ZN-c3 (and its potential metabolites as applicable), including but not limited to Cmax, Tmax, and AUC., Expansion: Plasma PK parameters of encorafenib including but not limited to Cmax, Tmax, and AUC., Expansion: Plasma PK parameters of ZN-c3 including but not limited to Cmax and AUC., Expansion: BRAF V600E mutational status.
Interventions
Sponsors
K-Group Beta Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose escalation: Incidence of DLTs (dose-limiting toxicities)., Expansion cohort: ORR by Investigator, defined as the proportion of participants who have achieved a confirmed BOR of CR or PR per RECIST version 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Escalation: Incidence and severity of AEs graded according to the NCI CTCAE v5.0 and changes in clinical laboratory parameters, vital signs and ECGs. Incidence of dose interruptions, dose modifications and discontinuations due to AEs., Escalation: ORR, DOR, PFS, DCR and TTR by Investigator., Escalation: Plasma PK parameters of ZN-c3 (and its potential metabolites as applicable), including but not limited to Cmax, Tmax, and AUC., Escalation: Plasma PK parameters of encorafenib including but not limited to Cmax, Tmax, and AUC., Expansion: DOR, PFS, DCR and TTR by Investigator., Expansion: Incidence and severity of AEs graded according to the NCI CTCAE v5.0 and changes in clinical laboratory parameters, vital signs and ECGs. Incidence of dosing interruptions, dose modifications and discontinuations associated with AEs., Expansion: Plasma PK parameters of ZN-c3 (and its potential metabolites as applicable), including but not limited to Cmax, Tmax, and AUC., Expansion: Plasma PK parameters | — |
Countries
Germany, Hungary, Italy, Poland, Spain
Outcome results
None listed