Clinical trial NCT04853017: A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Minimal Residual Disease
KRAS G12D
KRAS G12R
NRAS G12D
NRAS G12R
Pancreatic Ductal Adenocarcinoma
Colorectal Cancer
Non-small Cell Lung Cancer
Ovarian Cancer
Cholangiocarcinoma
Bile Duct Cancer
Gallbladder Carcinoma
Keywords: Minimal residual disease (MRD)
Kirsten rat sarcoma (KRAS)
Neuroblastoma ras viral oncogene homolog (NRAS)
Pancreatic ductal adenocarcinoma (PDAC)
Colorectal cancer (CRC)
Colon cancer
Rectal cancer
Non-small-cell lung cancer (NSCLC)
Mucinous Ovarian cancer
Cholangiocarcinoma (CCA)
Bile duct cancer
Gallbladder carcinoma
Immunotherapy
Vaccine therapy
Adjuvant therapy
circulating tumor DNA (ctDNA)
Lead sponsor: Elicio Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-04-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Participant Incidence of Treatment-emergent Adverse Events Considered by the Investigator as Related to ELI-002
timeFrame: Adverse events were collected through 28 days after the last dose
Secondary outcomes:
measure: The Proportion of Participants With Biomarker Reduction
timeFrame: 6 months
measure: The Proportion of Participants With Biomarker Clearance
timeFrame: 6 months
measure: The Proportion of Participants With Biomarker Reduction by Biomarker Type
timeFrame: 6 months
measure: The Proportion of Participants With Biomarker Clearance by Biomarker Type
timeFrame: 6 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Nashville
country: United States
facility: Tennessee Oncology - Centennial Clinic
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
References: