Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
65

Summary

Conditions
Advanced Cancer
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This is a first-in-human, dose escalation trial of an anti-CD47 antibody. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials. This study is composed of 3 stages: Part 1 dose escalation withou...

This is a first-in-human, dose escalation trial of an anti-CD47 antibody. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials. This study is composed of 3 stages: Part 1 dose escalation without priming dose, and Part 2 dose escalation with priming dose. Part 3 pharmacodynamic (PD)/ dose expansion cohort will open after the completion of Part 1 and 2.

Tracking Information

NCT #
NCT04257617
Collaborators
PPD
Investigators
Principal Investigator: Alex A Adjei, PhD Mayo Clinic College of Medicine and Science