Open
Actively Recruiting
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
About
Brief Summary
This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides]) as adjuvant treatment of minimal residual disease (MRD) in subjects with KRAS/neuroblastoma ras viral oncogene homolog (NRAS) mutated PDAC or other solid tumors.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- KRAS/NRAS mutated (G12D or G12R) solid tumor
- Positive for circulating tumor DNA (ctDNA) and/or elevated serum tumor biomarker despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable
- Screening CT is negative for recurrent disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Presence of tumor mutations where specific therapy is approved, and the patient is able to receive the approved therapy
- Known brain metastases
- Use of immunosuppressive drugs
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Study Stats
Protocol No.
21-000107
Category
Bladder Cancer
Breast Cancer
Cervical Cancer
Colorectal Cancer
Esophageal Cancer
Gallbladder Cancer
Head and Neck Cancer
Kidney Cancer
Liver Cancer
Lung Cancer
Melanoma (Skin Cancer)
Non-Melanoma Skin Cancer
Other Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Sarcoma
Stomach Cancer
Uterine/Endometrial Cancer
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood