First in Human Trials of ProAgio, a Cytotoxin

Division Of Basic Sciences - Nci

Investigators

Abstract

AIM1 (ongoing): To test safety, tolerability and pharmacokinetics (PK) of ProAgio in patients. We are planning a Phase I clinical study at the NIH Clinical Center in previously treated patients with advanced solid tumor malignancies to gain information about safety, tolerability, and pharmacokinetics of single agent ProAgio. Regulatory approvals have now been secured. AIM 2 (ongoing): To test the effect of ProAgio in combination with immunotherapeutics using pre-clinical models of PDAC. We are using novel syngeneic and autochthonous mouse models of pancreatic cancer to test whether ProAgio can improve delivery and anti-tumor efficacy of mesothelin-targeted immunotoxins, immune checkpoint inhibitors, and the combination. These studies could provide rationale for a future clinical trial of ProAgio combination therapy.