First in Human Phase I/II Trial of ELI-002 7P Immunotherapy as Treatment for Subjects with Kirsten Rat Sarcoma (KRAS)/Neuroblastoma RAS Viral Oncogene Homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and other Solid Tumors
Details
This is a Phase 1/2 study to assess the safety and efficacy of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides 7P]) as adjuvant treatment in subjects with solid tumors with mutated KRAS/NRAS. This study builds on the experience obtained with related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909.
Eligibility
You can join if...
Inclusion Criteria
-Patient who is 18 years or older
-Patient with histologically or cytologically confirmed diagnosis of solid tumor
-Patient who has recovered from prior surgery, chemotherapy, or radiation without any ongoing medical/surgical issues
Exclusion Criteria
-Patient who has received an anti-tumor therapy including investigational drug within 4 weeks prior to trail drug administration
-Patient who is currently receiving any agent with a known affect on the immune system, unless at dose levels that are not immunosuppressive
-Patient who is pregnant or lactating