Ovarian Cancer Clinical Trial
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
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.
Full Description
This is a Phase 1 dose escalation study in which ELI-002 2P (Amph modified KRAS peptides, Amph-G12D and Amph-G12R admixed with admixed Amph-CpG-7909) will be evaluated, with plans to transition to the ELI-002 7P drug product containing all 7 Amph-Peptides (G12D, G12R, G12V, G12A, G12C, G12S, G13D) in future clinical trials.
The study is an open-label, dose-escalation, 3+3 design in which approximately 18 subjects will be treated in 3 planned dose level cohorts. Increasing doses of Amph-CpG-7909 will be evaluated sequentially. Additional cohorts may be added to explore intermediate or higher dose levels based on cumulative safety review and preliminary review of pharmcodynamic responses. Safety and pharmacodynamic data will be evaluated and a recommended Phase 2 dose (RP2D) will be determined in consideration of a maximum tolerated dose (MTD) if observed.
Eligibility Criteria
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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There are 11 Locations for this study
Duarte California, 91010, United States More Info
Principal Investigator
Los Angeles California, 90095, United States More Info
Principal Investigator
Aurora Colorado, 80045, United States More Info
Principal Investigator
Iowa City Iowa, 52242, United States More Info
Principal Investigator
Boston Massachusetts, 02114, United States More Info
Principal Investigator
Detroit Michigan, 48202, United States
Saint Louis Missouri, 63110, United States
Lake Success New York, 11042, United States More Info
Principal Investigator
New York New York, 10065, United States More Info
Principal Investigator
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States More Info
Principal Investigator
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