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Clinical Trial Summary

This is an open-label, first-in-human (FIH) Phase I study to evaluate the safety, tolerability, and preliminary efficacy of a humanized anti-CD47 monoclonal antibody (HMPL-A83) in patients with advanced malignant neoplasm.


Clinical Trial Description

This is an open-label, first-in-human (FIH) Phase I study to evaluate the safety, tolerability, and preliminary efficacy of a humanized anti-CD47 monoclonal antibody (HMPL-A83) in patients with advanced malignant neoplasm. The sample size of this study is mainly based on the design of classical 3 + 3 combined accelerated titration dose escalation with a total of 6 dose groups, and approximately 31-84 patients are expected to be enrolled. During the dose escalation, DLT-nonevaluable patients will be replaced, or the actual number of patients enrolled may exceed the planned one due to adjustment of escalation schedule during the dose escalation. It is expected that no more than 99 patients will be enrolled. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05429008
Study type Interventional
Source Hutchmed
Contact Haiying Hong, CPM
Phone 17317300326
Email haiyingh@hutch-med.com
Status Recruiting
Phase Phase 1
Start date July 15, 2022
Completion date September 2025

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