A Phase 1/2 interventional study of V3-P in Pancreatic Cancer Non-resectable, sponsored by Immunitor LLC. Status unknown at 2 sites in Mongolia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-30.
Sponsored by Immunitor LLC · Phase 1/2, Interventional, and Treatment
Pancreatic cancer (PDA) is the most lethal form of cancer, and the fourth-leading cause of cancer-related death in the United States, with a survival rate of less than 7%.There are currently no treatments found to be effective for patients with advanced disease who are ineligible for surgery, a prognosis representing the majority of pancreatic cancer diagnoses. Pancreatic cancer is not amenable to chemotherapy as compared to other cancer types, leaving patients with practically no options except surgery.
We have made oral tableted therapeutic vaccine, V3-P, derived from pooled blood of patients with PDA in line with similar highly promising approach we have adopted for patients with hepatocellular carcinoma (HCC) and cholangiocarcinoma (CAA). Patients with PDA will be given one tablet per day of V3-P and followed up to see the outcome.
This study is an open label Phase II study aimed to recruit at least 20 patients with inoperable PDA and who are positive for CA19.9 pancreatic tumor marker. The presence of higher than normal levels of CA19.9 is the sole inclusion criteria. Patients will be given one tablet of V3-P daily and followed for three months.
Exclusion Criteria:
Daily tablet of V3-P given orally for 2 months
Biological: V3-P
one tablet of V3-P given once daily for 2 months
Also known as: oral tableted therapeutic vaccine
Effect of V3-P on tumor burden
Changes in CA19.9 tumor marker induced by daily dose of oral vaccine V3-P in an open label trial in patients with inoperable pancreatic cancer.
Time frame: 3 months
Safety of V3-P
Toxicity or adverse side effects, such as diarrhea and vomiting, will be graded according to accepted standards, e.g., NCI CTEP CTCAE.
Time frame: 3 months
Effect of V3-P on sugar and bilirubin levels
Monthly evaluation of fasting glucose and bilirubin levels as a surrogate for pancreatic function
Time frame: 3 months
Plan to share: Undecided — The data will be shared with other researchers upon request on study conclusion
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Immunitor LLC