An Experimental Medicine, Low Grade Interventional, Clinical Study to Compare Peripheral Immune System From Subjects Without Cancer Diagnosis and Patients With Advanced Solid Tumours
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Immune System
- Sponsor
- Servier
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Standard differential blood count
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of the study is to gain knowledge concerning expression of immune markers on immune cell subpopulation of PBMCs from subjects without cancer diagnosis and cancer patients. Few studies have addressed the question of the difference of peripheric immune cells between these two populations without a specific focus on an immune cell population or an indication, and with a multiparametic approach. The present study will combine phenotypic (using cell population markers and immune checkpoints) and functional analyses toallow to better interpret non-clinical results obtained with either subjects without cancer or cancer patient material and provide rationale to use material from subjects without cancer diagnosis for functional tests. It would also argument a go to healthy volunteer's clinical trials for assessing peripheral pharmacodynamic (PD), receptor occupancy (RO) and safety (Cytokine release syndrome, CRS), in the context of early drug development in immuno-oncology. Finally, generated data will be used to feed quantitative system pharmacology (QSP) models to increase their robustness and better predict drug pharmacology in humans.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Standard differential blood count
Time Frame: 1 day
flow cytometry analysis