Clinical trialPhase 1 / Phase 2Completed
Safety and Efficacy Study of 90Y-hPAM4 at Different Doses
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
- Outcome
- Finished, no results posted
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- August 2004
- Expected end
- October 2007
- Enrollment
- 21 participants
- Sites
- 4
- Primary outcomes
- safety MTD
- Sponsor
- Industry
- Results posted
- No
- Last update
- 19 August 2021
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Brief summary public domain (ClinicalTrials.gov)
Safety study to determine highest dose of 90Y-hPAM4 can be safety administered
Detailed description public domain (ClinicalTrials.gov)
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.