PhI/II of ELI-002 7P as Tx for Subjects w/ KRAS/NRAS Viral Oncogene Homolog Mutated Solid Tumors

UCI Specialty Area: Cancer

Principal Investigator: Jennifer Brooke Valerin

Official Title: First in Human Phase I/II Trial of ELI-002 7P Immunotherapy as Treatment for Subjects with Kirsten Rat Sarcoma (KRAS)/Neuroblastoma RAS Viral Oncogene Homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and other Solid Tumors

A Study On:

Anus

Bones and Joints

Brain and Nervous System

Breast

Cervix

Colon

Corpus Uteri

Esophagus

Eye and Orbit

Ill-Defined Sites

Kaposis sarcoma

Kidney

Larynx

Lip Oral Cavity and Pharynx

Liver

Lung

Melanoma skin

Mycosis Fungoides

Other Digestive Organ

Other Endocrine System

Other Female Genital

Other Male Genital

Other Respiratory and Intrathoracic Organs

Other Skin

Other Urinary

Ovary

Pancreas

Prostate

Rectum

Small Intestine

Soft Tissue

Stomach

Thyroid

Unknown Sites

Urinary Bladder

Study Description

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.

Eligibility

-Patient who is 18 years or older

-Patient with histologically or cytologically confirmed diagnosis of solid tumor

-Patient who has recovered from prior surgery, chemotherapy, or radiation without any ongoing medical/surgical issues

-Patient who has received an anti-tumor therapy including investigational drug within 4 weeks prior to trail drug administration

-Patient who is currently receiving any agent with a known affect on the immune system, unless at dose levels that are not immunosuppressive

-Patient who is pregnant or lactating

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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