Clinical trial · Interventional
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
NCT00597129CI-TRIAL-00053380completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Safety study to determine highest dose of 90Y-hPAM4 can be safety administered
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 90Y-hPAM4 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multi Dose levels
- description
- different doses of 90YhPAM4 will be given only once.
- interventionNames
- Biological: 90Y-hPAM4
Primary outcomes (1)
- measure
- safety MTD
- timeFrame
- over the first 12 weeks, then over 2 years
Secondary outcomes (3)
- measure
- targeting, biodistribution, organ dosimetry
- timeFrame
- first 2 weeks
- measure
- pharmacokinetics (PK), antigenicity,
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients, \>18 years of age, who are able to understand and give written informed consent. * Histologically or cytologically confirmed, Stage III or IV pancreatic adenocarcinoma. * Patients with Stage III (locally advanced) disease must have documented progression after failing primary therapy * Patients with Stage IV (metastatic) disease must not have received more than one chemotherapy regimen. * Measurable disease by CT, with at least on lesion \>1.5 cm in one dimension. * Karnofsky performance status \> 70 % (Appendix A). * Expected survival \> three months. * At least 4 weeks beyond chemotherapy, radiotherapy, major surgery, other experimental treatments, and recovered from all acute toxicities. * At least 2 weeks beyond corticosteroids, except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis * Adequate hematology without ongoing transfusional support (hemoglobin \> 10 g/dL, ANC \> 1,500 per mm3, platelets \> 150,000 per mm3) * Adequate renal and hepatic function (creatinine and bilirubin ≤ 1.5 X IULN, AST and ALT ≤ 2.0 X IULN) * Otherwise, all toxicity at study entry \<Grade 1 by NCI CTC v3.0. Exclusion Criteria: * Women who are pregnant or lactating. * Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period. * Known metastatic disease to the central nervous system. * Presence of bulky disease (defined as any single mass \>10 cm in its greatest dimension) * Patients with \>Grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction. * Prior treatment with nitrosureas, actinomycin-D, radioimmunotherapy or other antibody-based therapies (murine, chimeric, humanized or human) Prior radiation dose \>3,000 cGy to the liver, \>2,000 cGy to lungs and kidneys or prior external beam irradiation to a field that includes more than 30% of the red marrow. * Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least a 5- year disease free interval. * Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive. * Known history of active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months or cardiac arrhythmia requiring anti-arrhythmia therapy. * Known history of active COPD, or other moderate-to-severe respiratory illness present within 6 months. * Known autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids). * Infection requiring intravenous antibiotic use within 1 week. * Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation
References
Publications (17)
- BACKGROUNDGold DV, Karanjawala Z, Modrak DE, Goldenberg DM, Hruban RH. PAM4-reactive MUC1 is a biomarker for early pancreatic adenocarcinoma. Clin Cancer Res. 2007 Dec 15;13(24):7380-7. doi: 10.1158/1078-0432.CCR-07-1488. PMID 18094420
- BACKGROUNDModrak DE, Gold DV, Goldenberg DM. Sphingolipid targets in cancer therapy. Mol Cancer Ther. 2006 Feb;5(2):200-8. doi: 10.1158/1535-7163.MCT-05-0420. PMID 16505092
- BACKGROUNDGold DV, Modrak DE, Ying Z, Cardillo TM, Sharkey RM, Goldenberg DM. New MUC1 serum immunoassay differentiates pancreatic cancer from pancreatitis. J Clin Oncol. 2006 Jan 10;24(2):252-8. doi: 10.1200/JCO.2005.02.8282. Epub 2005 Dec 12. PMID 16344318
- BACKGROUNDModrak DE, Karacay H, Cardillo TM, Newsome G, Goldenberg DM, Gold DV. Identification of a Mu-9 (anti-colon-specific antigen-p)-reactive peptide having homology to CA125 (MUC16). Int J Oncol. 2005 Jun;26(6):1591-6. PMID 15870874
- BACKGROUNDModrak DE, Cardillo TM, Newsome GA, Goldenberg DM, Gold DV. Synergistic interaction between sphingomyelin and gemcitabine potentiates ceramide-mediated apoptosis in pancreatic cancer. Cancer Res. 2004 Nov 15;64(22):8405-10. doi: 10.1158/0008-5472.CAN-04-2988. PMID 15548711
- BACKGROUNDGold DV, Modrak DE, Schutsky K, Cardillo TM. Combined 90Yttrium-DOTA-labeled PAM4 antibody radioimmunotherapy and gemcitabine radiosensitization for the treatment of a human pancreatic cancer xenograft. Int J Cancer. 2004 Apr 20;109(4):618-26. doi: 10.1002/ijc.20004. PMID 14991585
- BACKGROUNDGold DV, Schutsky K, Modrak D, Cardillo TM. Low-dose radioimmunotherapy ((90)Y-PAM4) combined with gemcitabine for the treatment of experimental pancreatic cancer. Clin Cancer Res. 2003 Sep 1;9(10 Pt 2):3929S-37S. PMID 14506191