Microsatellite stable colorectal cancer patients
Conditions
Brief summary
The main study endpoint is to determine the RP2D of LB−100 when administered in combination with standard doses of Atezolizumab, by assessing the maximum tolerated dose and incidences of adverse events.
Detailed description
The efficacy will be evaluated using the disease control rate, objective response rate, progression free survival, overall survival and duration of response., A pharmacokinetic profile of Atezolizumab, LB−100 and the active metabolite endothall will be included by measuring plasma concentrations and determining the pharmacokinetic parameters (e.g. maximal plasma concentration, area under the curve, half–life)., Additionally, relevant pharmacodynamics biomarkers will be explored.
Interventions
Sponsors
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is to determine the RP2D of LB−100 when administered in combination with standard doses of Atezolizumab, by assessing the maximum tolerated dose and incidences of adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| The efficacy will be evaluated using the disease control rate, objective response rate, progression free survival, overall survival and duration of response., A pharmacokinetic profile of Atezolizumab, LB−100 and the active metabolite endothall will be included by measuring plasma concentrations and determining the pharmacokinetic parameters (e.g. maximal plasma concentration, area under the curve, half–life)., Additionally, relevant pharmacodynamics biomarkers will be explored. | — |
Countries
Netherlands
Outcome results
None listed