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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1A: ELI-002 7P (Low Peptide dose) | Experimental | ELI-002 Amph-CpG-7909 (10.0mg) admixed with ELI-002 Amph-Peptides 7P (1.4mg) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing) |
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| Phase 1A: ELI-002 7P (High Peptide dose) | Experimental | ELI-002 Amph-CpG-7909 (10.0mg) admixed with ELI-002 Amph-Peptides 7P (4.9mg) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing) |
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| Phase 1B: ELI-002 7P | Experimental | The ELI-002 7P dose selected during the Phase 1A portion of the study will be administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing) |
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| Phase 2 randomized: ELI-002 7P | Experimental | The ELI-002 7P dose selected during the Phase 1A portion of the study will be administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELI-002 7P | Drug | ELI-002 Amph-CpG-7909 admixed with ELI-002 Amph-Peptides 7P 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 weeks during the Booster Period (the two periods are separated by 2 months of no dosing) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Evaluate the safety of ELI-002 7P | Safety will be assessed by the incidence of adverse events (AEs) and clinically significant changes in laboratory tests and vital signs | 28 days after the first dose of ELI-002 7P |
| Phase 2: Compare ELI-002 7P versus standard of care (SOC; observation) in DFS (disease free survival) | DFS is assessed by the investigator through computed tomography (CT) imaging or magnetic resonance imaging (MRI) with contrast and using iRECIST criteria | After the last radiographic assessment at Visit 26 (Week 150) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Overall Survival (OS) | To compare OS between cohorts, ELI-002 7P vs Observation | After Visit 13 (Week 20) |
| Phase 1 and Phase 2: Determine the biomarker reduction or clearance rate | The ctDNA reduction or clearance is defined as reduction or clearance of ctDNA from baseline, or if ctDNA was not detectable at baseline, serum tumor biomarker (such as CA19-9 and CEA) reduction and clearance compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Mayo Clinic Comprehensive Cancer Center |
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| 6 months |
| Phase 2: Determine the 1-year DFS | Compare between cohorts, ELI-002 7P vs Observation, the 1-year DFS | 1 year |
| Phase 2: Evaluate the safety of ELI-002 7P | Safety will be assessed by the incidence of AEs and clinically significant laboratory tests and vital signs | 30 days after the last ELI-002 7P dose |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| City of Hope | Duarte | California | 91010 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| University of California, Irvine | Orange | California | 92868 | United States |
| University of Colorado Hospital-Anschutz Cancer Pavillion | Aurora | Colorado | 80045 | United States |
| University of Miami | Coral Gables | Florida | 33124 | United States |
| University of Florida Health Cancer Center | Gainesville | Florida | 32610 | United States |
| Mayo Clinic Comprehensive Cancer Center | Jacksonville | Florida | 32224 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Emory Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Ochsner Health | New Orleans | Louisiana | 70121 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02210 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic Comprehensive Cancer Center | Rochester | Minnesota | 55905 | United States |
| Northwell Health | Lake Success | New York | 11042 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10022 | United States |
| New York Presbyterian Weill Cornell Medical Center | New York | New York | 10065 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18003 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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