First in Human Phase 1 Trial of ELI-002 Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS) Mutated Pancreatic Ductal Adenocarcinoma and Other Solid Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 10
- Primary Endpoint
- The Participant Incidence of Treatment-emergent Adverse Events Considered by the Investigator as Related to ELI-002
Study Overview
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.
Detailed 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 pharmacodynamic 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ELI-002 2P Cohort 4
ELI-002 2P Amph-CpG-7909 (5.0 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization period; additional SC injections weekly for 4 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
Intervention: ELI-002 2P (Drug)
ELI-002 2P Cohort 5
ELI-002 2P Amph-CpG-7909 (10.0 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization period; additional SC injections weekly for 4 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
Intervention: ELI-002 2P (Drug)
ELI-002 2P Cohort 3
ELI-002 2P Amph-CpG-7909 (2.5 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization period; additional SC injections weekly for 4 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
Intervention: ELI-002 2P (Drug)
ELI-002 2P Cohort 2
ELI-002 2P Amph-CpG-7909 (0.5 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization period; additional SC injections weekly for 4 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
Intervention: ELI-002 2P (Drug)
ELI-002 2P Cohort 1
ELI-002 2P Amph-CpG-7909 (0.1 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via subcutaneous (SC) injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization period; additional SC injections weekly for 4 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
Intervention: ELI-002 2P (Drug)
Outcomes
Primary Outcomes
The Participant Incidence of Treatment-emergent Adverse Events Considered by the Investigator as Related to ELI-002
Time Frame: Adverse events were collected through 28 days after the last dose
The safety of ELI-002 was monitored through adverse events, including those considered related to treatment by the investigator
Secondary Outcomes
- The Proportion of Participants With Biomarker Reduction(6 months)
- The Proportion of Participants With Biomarker Clearance(6 months)
- The Proportion of Participants With Biomarker Reduction by Biomarker Type(6 months)
- The Proportion of Participants With Biomarker Clearance by Biomarker Type(6 months)