Ovarian Cancer Clinical Trial

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

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.

View Full Description

Full 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.

This 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. 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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT04853017

Recruitment Status:

Recruiting

Sponsor:

Elicio Therapeutics

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There are 11 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States More Info
Vincent Chung, MD
Contact
626-218-8900
[email protected]
City of Hope Clinical Trials Line
Contact
626-218-1133
Vincent Chung, MD
Principal Investigator
University of California Los Angeles
Los Angeles California, 90095, United States More Info
Lisa Yonemoto
Contact
310-633-8400
[email protected]
Zev Wainberg, MD
Principal Investigator
University of Colorado
Aurora Colorado, 80045, United States More Info
McKenna Russen
Contact
720-848-8785
[email protected]
Alexis Leal, MD
Principal Investigator
University of Iowa
Iowa City Iowa, 52242, United States More Info
Alyssa Pratt
Contact
[email protected]
Muhammed Furqan, MD
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Colin D Weekes, MD
Contact
617-724-4000
[email protected]
Colin D Weekes, MD
Principal Investigator
Henry Ford Cancer Institute
Detroit Michigan, 48202, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Northwell Health
Lake Success New York, 11042, United States More Info
Craig Devoe, MD
Contact
516-734-8896
Craig Devoe, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Research Manager
Contact
646-888-4327
[email protected]
Eileen M O'Reilly, MD
Contact
646-888-4182
Eileen M O'Reilly, MD
Principal Investigator
Tennessee Oncology - Centennial Clinic
Nashville Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Mercy David
Contact
832-421-7290
[email protected]
Shubham Pant, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT04853017

Recruitment Status:

Recruiting

Sponsor:


Elicio Therapeutics

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