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Clinical Trials/NCT05133128
NCT05133128
Terminated
Not Applicable

An Experimental Medicine, Low Grade Interventional, Clinical Study to Compare Peripheral Immune System From Subjects Without Cancer Diagnosis and Patients With Advanced Solid Tumours

Servier2 sites in 1 country36 target enrollmentNovember 25, 2021
ConditionsImmune System

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.

Registry
clinicaltrials.gov
Start Date
November 25, 2021
End Date
July 21, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Servier
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Standard differential blood count

Time Frame: 1 day

flow cytometry analysis

Study Sites (2)

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