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

Cancer
Jennifer Brooke Valerin
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
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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