The purpose of this study is to assess the safety and tolerability of gentulizumab, an anti-CD47 Monoclonal Antibody, in participants with solid tumors and non-Hodgkin lymphoma.
This is a first-in-human, escalating dose trial of an antibody that inhibits an anti-apoptotic signal in human macrophages. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Gentulizumab is administered IV once a week, with every 4 weeks as an administration cycle.
Jian Zhang
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Safety and Tolerability of Gentulizumab as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs).
The CTCAE criteria will be used to assess adverse events on this trial.
Time frame: 28 days
Pharmacokinetic (PK) Parameter: Area under the plasma concentration versus time curve (AUC).
Time frame: From the first dosing to 90 days after the last dosing
Pharmacokinetic (PK) Parameter: Peak plasma concentration (Cmax).
Time frame: From the first dosing to 90 days after the last dosing
Pharmacokinetic (PK) Parameter: Terminal phase half-life (t1/2).
Time frame: From the first dosing to 90 days after the last dosing
Pharmacodynamic (PD) Characteristics of Gentulizumab.
PD parameters include: receptor occupancy (RO) of gentulizumab of red blood cells, and white blood cells in peripheral blood.
Time frame: From the first dosing to 90 days after the last dosing
Immunogenicity of Gentulizumab.
Numbers of anti-drug antibody (ADA) and/or neutralizing antibody (NAb) positive participants will be used to assess the immunogenicity of gentulizumab.
Time frame: From the first dosing to 28 days after the last dosing
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