Clinical trialEPhase 1Terminated
Safety Study to Determine the Appropriate Dose of Antibody Against Tumor Cells to Best Target Patients With Pancreatic Cancer.
Pharmacokinetics, Biodistribution and Targeting of 111 In- Labeled Humanized PAM4IgG in Pre-Surgical Pancreatic Cancer Patients.An Examination of Protein Dose
- Outcome
- Stopped earlyLoss of funding (Business decision)
- Phase
- EPhase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- May 2007
- Expected end
- August 2008
- Enrollment
- 2 participants
- Sites
- 1
- Primary outcomes
- 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.; An examination of how the pharmacokinetics and tumor targeting are affected by the amount of hPAM4 IgG administered.; Targeting with 111In-hPAM4 will be compared to other radiological (e.g., CT) and nuclear (FDG-PET; optional)findings.; For patients who undergo surgery after the 111In-hPAM4 study, targeting will be correlated against surgical findings.
- Sponsor
- Other
- Results posted
- No
- Last update
- 18 January 2019
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Brief summary public domain (ClinicalTrials.gov)
This no treatment research study is being done to find a safe and an appropriate dose of antibody (protein) against tumor cells to best target the cancer in people with pancreatic cancer. To do this, this no-treatment research study will compare two doses of an antibody called hPAM4 IgG when combined with a radioactive element, Indium-111.
Detailed description public domain (ClinicalTrials.gov)
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.