A Phase I, Dose-Escalating Study to Investigate the Safety, Tolerability, Pharmacokinetics and Dosimetry of a Single Dose of 90YHumanized PAM4 IgG in Patients With Locally Advanced/Metastatic Pancreatic Cancer
radiolabeled anti-MUC1 humanized antibody) administered intravenously as a single dose to
patients with locally advanced and/or metastatic pancreatic cancer. The primary objective is
to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of 90Y-hPAM4
in this population. Secondary objectives include the assessment of tumor targeting,
biodistribution, organ dosimetry and pharmacokinetics (PK) of 90Y-hPAM4 as determined by
pre-therapy administration of 111In-hPAM4, the assessment of the antigenicity of 90Y-hPAM4,
as determined by development of human anti-humanized antibodies (HAHA), and to obtain
preliminary information on the efficacy of single dose 90Y-hPAM4 in this patient population.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
safety MTD
over the first 12 weeks, then over 2 years
Yes
William Wegener, MD, PhD
Study Chair
Immunomedics, Inc.
United States: Food and Drug Administration
IM-T-hPAM4-01
NCT00597129
August 2004
October 2007
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Nebraska Medical Center | Omaha, Nebraska 68198 |
Goshen Cancer Center | Goshen, Indiana 46526 |
University of Medicine and Dentistry | Newark, New Jersey 07101 |