Pharmacokinetics, Biodistribution and Targeting of 111 In- Labeled Humanized PAM4IgG in Pre-Surgical Pancreatic Cancer Patients.An Examination of Protein Dose
This is an open-label, single-center, non-randomized, single-arm, pilot imaging study to
determine the pharmacokinetics, biodistribution, and tumor targeting of an indium-111
(111In)-labeled, humanized anti-MUC1 antibody, designated hPAM4 IgG1 in patients with known
pancreatic cancer. The primary objective of this trial is to examine how changing the
protein dose will affect these parameters with the intent to determine if a single protein
dose can be selected to optimize tumor targeting. It is expected that these data will aid
in the selection of an appropriate protein dose to be used in a Phase I therapy trial with
yttrium-90 (90Y)-labeled hPAM4 IgG. The secondary objective is to monitor safety.
Pharmacokinetics, biodistribution, tumor targeting, and dosimetry (modeling for 90Y) will be
assessed against clinical parameters, such as pre-study PAM4-reactive MUC-1 antigen in the
serum, tumor size, location, histopathology, immunohistology, and if possible, antigen
content by extraction of tumor sample.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Examine the pharmacokinetics and tumor targeting of 111In-DOTA-hPAM4 anti-MUC-1 IgG given intravenously to patients with known or a suspicion of primary or recurrent pancreatic cancer.
Richard Wahl, MD
Johns Hopkins Institution
United States: Food and Drug Administration
|Johns Hopkins Institution, Dept of Radiology and Radiological Science||Baltimore, Maryland 21287|