History of Changes for Study: NCT04853017

A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumor (AMPLIFY-201)

Latest version (submitted April 11, 2024) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	April 16, 2021	None (earliest Version on record)
2	April 26, 2021	Contacts/Locations and Study Status
3	April 29, 2021	Contacts/Locations and Study Status
4	May 12, 2021	Study Status and Contacts/Locations
5	May 25, 2021	Contacts/Locations and Study Status
6	June 3, 2021	Contacts/Locations and Study Status
7	June 8, 2021	Contacts/Locations and Study Status
8	June 11, 2021	Contacts/Locations and Study Status
9	June 30, 2021	Contacts/Locations and Study Status
10	July 1, 2021	Study Status and Contacts/Locations
11	July 27, 2021	Contacts/Locations and Study Status
12	July 30, 2021	Contacts/Locations and Study Status
13	August 2, 2021	Study Status and Contacts/Locations
14	August 10, 2021	Contacts/Locations and Study Status
15	October 6, 2021	Arms and Interventions, Outcome Measures, Study Status, Study Design, Contacts/Locations, Study Description, Study Identification, Eligibility and Conditions
16	October 13, 2021	Arms and Interventions, Study Design and Study Status
17	November 29, 2021	Study Status
18	December 16, 2021	Study Status and Contacts/Locations
19	January 21, 2022	Study Status
20	February 22, 2022	Study Status
21	March 8, 2022	Contacts/Locations and Study Status
22	April 18, 2022	Study Status and Arms and Interventions
23	May 20, 2022	Study Status and Eligibility
24	June 17, 2022	Contacts/Locations and Study Status
25	July 18, 2022	Contacts/Locations and Study Status
26	August 15, 2022	Study Status and Contacts/Locations
27	September 14, 2022	Contacts/Locations and Study Status
28	October 17, 2022	Study Status
29	November 21, 2022	Study Status
30	December 21, 2022	Study Status
31	December 27, 2022	Outcome Measures, Arms and Interventions, Study Description and Study Status
32	January 18, 2023	Study Status
33	February 6, 2023	Study Status
34	February 8, 2023	Study Status
35	April 14, 2023	Study Status
36	April 25, 2023	Recruitment Status, Contacts/Locations, Study Status and Study Design
37	May 15, 2023	Study Status
38	June 23, 2023	Study Status
39	July 17, 2023	Study Status
40	August 21, 2023	Study Status
41	September 19, 2023	Study Status
42	November 21, 2023	Study Status
43	December 19, 2023	Study Status
44	February 21, 2024	Study Status
45	March 18, 2024	Study Status
46	April 11, 2024	Study Status

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Study NCT04853017
Submitted Date: April 16, 2021 (v1)

Study Identification


Unique Protocol ID:	ELI-002-001
Brief Title:	A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumor (AMPLIFY-201)
Official Title:	First in Human Phase 1/2 Trial of ELI-002 Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS) Mutated Pancreatic Ductal Adenocarcinoma and Other Solid Tumors
Secondary IDs:

Study Status


Record Verification:	April 2021
Overall Status:	Recruiting
Study Start:	March 19, 2021
Primary Completion:	March 2025 [Anticipated]
Study Completion:	March 2025 [Anticipated]

First Submitted:	April 16, 2021
First Submitted that Met QC Criteria:	April 16, 2021
First Posted:	April 21, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	April 16, 2021
Last Update Posted:	April 21, 2021 [Actual]

Study Description

Brief Summary:

This is a Phase 1/2 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 tumor.

Detailed Description:

The study consists of 3 phases: Phase 1A, Phase 1B, and Phase 2. In Phase 1A, Amph modified KRAS peptides, Amph-G12D and Amph-G12R (ELI-002 2P) will be evaluated with admixed Amph-CpG-7909, with plans to transition to an Amph-Peptide 7P drug product containing all 7 Amph-Peptides (G12D, G12R, G12V, G12A, G12C, G12S, G13D) for Phase 1B dose expansion and Phase 2 studies.

The Phase 1A portion of the study is an open-label, dose-escalation, 3+3 design in which up to 18 subjects will be treated in 3 planned dose level cohorts. In this phase, increasing doses of Amph-CpG-7909 will be evaluated sequentially. 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.

In Phase 1B, three dose expansion cohorts (up to 17 subjects in each cohort for a total of up to 51 subjects) will be added to evaluate for preliminary evidence of antitumor activity in KRAS and NRAS mutated solid tumors (including colorectal cancer, non-small cell lung cancer, mucinous ovarian cancer, as well as bile duct and gallbladder cancer) and changes from baseline in tumor biomarkers.

In Phase 2, an additional 90 pancreatic cancer subjects will be randomized 2:1 (ELI-002 versus observation) to further evaluate antitumor activity. Subjects randomized to ELI-002 will receive subcutaneous (SC) injections of ELI-002 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 but will not receive ELI-002 treatment. Subjects randomized to observation will be able to cross-over to ELI-002 treatment in the event of confirmed disease progression.

Conditions


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

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1/Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	159 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: ELI-002 (Phase 1A) Dose escalation	Drug: ELI-002 (Dose Escalation) Amph-CpG-7909 admixed with Amph modified KRAS peptides 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)
Experimental: ELI-002 (Phase 1B) Dose expansion at RP2D	Drug: ELI-002 (at the RP2D) Amph-CpG-7909 admixed with Amph modified KRAS peptides 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) at the dose determined to be the recommended dose in Phase 1A
Experimental: ELI-002 or Observation (Phase 2, randomized) Subjects randomized to ELI-002 will receive ELI-002 at the RP2D. Subjects randomized to Observation will not receive ELI-002 intervention, however they will have the possibility to receive treatment following confirmed disease progression.	Drug: ELI-002 (at the RP2D) Amph-CpG-7909 admixed with Amph modified KRAS peptides 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) at the dose determined to be the recommended dose in Phase 1A Observation Observation only (no ELI-002 treatment)

Outcome Measures


Primary Outcome Measures:
1.	Phase 1A: Determine the MTD of ELI-002 and the RP2D [ Time Frame: 28 days after first dose ] The MTD is defined as the highest dose level for which <33% of subjects had a dose-limiting toxicity.
2.	Phase 1: Evaluate the safety of ELI-002 [ Time Frame: 30 days after last dose ] Safety will be assessed by the incidence of adverse events (AEs) and clinically significant laboratory tests and vital signs.
3.	Phase 2: Determine whether ELI-002 improves relapse-free survival (RFS) compared with Observation [ Time Frame: After the last radiographic assessment at Visit 24 (Day 791) ] RFS is assessed by the investigator through computed tomography (CT) imaging with contrast and using iRECIST criteria.
Secondary Outcome Measures:
1.	Phase 1: Determine the ctDNA clearance rate [ Time Frame: 6 months ] The ctDNA clearance rate is defined as the proportion of subjects whose ctDNA status changes from positive at baseline to negative at 6 months.
2.	Phase 2: Evaluate the safety of ELI-002 [ Time Frame: 30 days after the last ELI-002 dose ] Safety will be assessed by the incidence of AEs and clinically significant laboratory tests and vital signs.
3.	Phase 2: Determine the ctDNA clearance [ Time Frame: 6 months ] Compare between treatments, ELI-002 vs Observation, the proportion of subjects whose ctDNA status changes from positive at baseline to negative at 6 months.
4.	Phase 2: Determine the 1-year RFS [ Time Frame: 1 year ] Compare between treatments, ELI-002 vs Observation, the 1-year RFS.
5.	Phase 2: Determine the overall survival (OS) [ Time Frame: 24 months ] Compare between treatments, ELI-002 vs Observation, assuming proportional hazards, the OS (defined as the time from randomization to death).
6.	Phase 2: Determine the objective response rate (ORR) in subjects who crossover from Observation to ELI-002 after confirmed relapse [ Time Frame: After Visit 15 (Day 217) ] ORR is defined as the proportion of subjects achieving a complete response or a partial response per iRESIST.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: KRAS/NRAS mutated (G12D or G12R) solid tumor Positive for circulating tumor DNA 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 Known brain metastases Use of immunosuppressive drugs

Contacts/Locations


Central Contact Person:	Clinical Trial Inquiries Telephone: 617-714-9884 Email: clinicaltrialinquiries@elicio.com
Locations:	United States, Michigan
	Henry Ford Cancer Institute [Recruiting] Detroit, Michigan, United States, 48202 Contact:Principal Investigator: Ding M Wang, MD
	United States, Missouri
	Washington University School of Medicine [Recruiting] Saint Louis, Missouri, United States, 63110 Contact:Contact: Katlyn Kraft 314-747-5440 katlyn.kraft@wustl.edu Contact:Principal Investigator: Haeseong Park, MD
	United States, New York
	Memorial Sloan Kettering Cancer Center [Active, not recruiting] New York, New York, United States, 10065
	United States, Tennessee
	Tennessee Oncology - Centennial Clinic [Recruiting] Nashville, Tennessee, United States, 37203 Contact:Contact: 844-482-4812 DDUReferrals@sarahcannon.com Contact:Principal Investigator: Melissa Johnson, MD
	United States, Texas
	The University of Texas MD Anderson Cancer Center [Recruiting] Houston, Texas, United States, 77030 Contact:Contact: Mercy David 832-421-7290 MFDavid@mdanderson.org Contact:Contact: Li Xu 713-745-2416 lixu@mdanderson.org Contact:Principal Investigator: Shubham Pant, MD

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