A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
Colon/Rectal Cancer
Lung Cancer
Solid Tumor
18 Years and older, Male and Female
ELI-002-201 (primary)
NCI-2023-01631
Summary
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.
Objectives
The study consists of 3 phases: Phase 1A, Phase 1B, and Phase 2. In Phase 1A, seven Amph
modified KRAS and NRAS peptides, G12D, G12R, G12V, G12A, G12C, G12S, G13D (Amph-Peptides
7P) will be evaluated in combination with recommended Phase 2 dose of Amph-CpG-7909
(10.0mg). This Amph-CpG-7909 dose will be evaluated with two Amph-Peptides 7P dose levels
(1.4mg and 4.9mg) in 6 subjects per dose level. Following enrollment of these 12
subjects, the independent data monitoring committee (IDMC) will decide if another 6
subjects should be enrolled or if the dose can be determined for Phase 1B and Phase 2
portions of the study to be opened. If another 6 subjects are enrolled to Phase 1A, the
IDMC will meet again to decide upon the dose for Phase 1B and Phase 2 prior to opening
these portions of the study.
In Phase 1B, one dose expansion cohort of up to 17 colorectal cancer [CRC] subjects may
be added to evaluate for preliminary evidence of biomarker response, including
circulating tumor deoxyribonucleic acid (ctDNA) and/or serum tumor biomarker (such as
CA19-9 and CEA) reduction and clearance in KRAS and NRAS.
In Phase 2, an additional 135 PDAC subjects will be randomized 2:1 (ELI-002 7P versus
observation) to further evaluate antitumor activity. Subjects randomized to ELI-002 7P
will receive subcutaneous (SC) injections of ELI-002 7P during Immunization and Booster
Periods. Subjects randomized to observation will have the same safety and efficacy
evaluations and will follow the same assessment schedule as subjects randomized to
ELI-002 7P but will not receive study treatment. Subjects randomized to observation will
be able to elect to cross-over to ELI-002 7P treatment in the event of confirmed disease
progression.
Eligibility
- KRAS/NRAS mutated (G12D, G12R, G12V, G12A, G12C, G12S, G13D) solid tumor
- Phase 1 only: positive for circulating tumor DNA and/or elevated serum tumor biomarkers (such as CA19-9 and CEA) 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
Treatment Sites in Georgia
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