This is an open label, first-in-human, phase 1, dose escalation study to determine the safety
including dose limiting toxicity (DLT) and maximal tolerated dose of the monoclonal antibody
NEO-201 in adults with solid tumors (cancer) which has not responded to standard treatments.
The experimental drug called NEO-201 (the "study drug") is a monoclonal antibody that is
being tested and is not approved for use in the United States by the FDA.
The primary purpose of this first in human targeted phase 1 open-label study with NEO-201 in
subjects with advanced solid tumors is to determine the safety of NEO-201 and select a dose
for phase 2 clinical trials.
NEO-201 will be given in four increasing doses to make sure it is safe. NEO-201 will start at
a low dose (1 mg/kg) and be increased 3 times (2, 4, 6 mg/kg) over the period of the study in
different groups of subjects. Subjects who enroll during the early stages of the study, will
receive a lower dose of NEO-201, those who enroll later, will receive a higher dose that may
be associated with more side effects.
Clinical Study Identifier
Precision Biologics, Inc
Last Modified on
23 January 2021
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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