QUILT-2.025 NANT Neoepitope Yeast Vaccine (YE-NEO-001): Adjuvant Immunotherapy Using a Personalized Neoepitope Yeast-Based Vaccine To Induce T-Cell Responses In Subjects W/ Previously Treated Cancers.

NCT03552718 | Completed Phase 1 FDA Drug

• 1 other identifier: QUILT-2.025
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1 study to evaluate the safety, the Recommended Phase 2 Dose (RP2D), and preliminary efficacy of a personalized neoepitope yeast-based vaccine, YE-NEO-001, in subjects who have completed potentially curative therapy for their solid cancer and who would otherwise be entering a period of surveillance for recurrent disease.

Conditions

Colorectal Cancer; Breast Cancer; Head and Neck Squamous Cell Carcinoma; Melanoma; Non Small Cell Lung Cancer; Pancreatic Cancer; Liver Cancer

Keywords

solid tumors

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-emergent adverse events

  19 months

• Recommended Phase 2 Dose

  19 months

Secondary Outcomes (4)

• Recurrence rate

  19 months

• Disease-free survival (DFS)

  24 months

• Overall survival (OS)

  36 months

• Progression-free survival (PFS)

  24 months

Study Arms (1)

Experimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001)

EXPERIMENTAL

Biological: YE-NEO-001

Interventions

YE-NEO-001 BIOLOGICAL

Personalized recombinant yeast-based vaccine engineered to express multiple neoantigen epitopes (neoepitopes) based on an individual subject's tumor molecular profile.

Also known as: YE-NEO-001 Injectable Suspension

Experimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre-treatment Phase: Tissue Procurement and Development of Vaccine
• Age ≥ 18 years old.
• Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
• Histologically-confirmed cancer amenable to treatment with curative intent as part of SoC. Must be willing to provide a tumor tissue sample (either a tumor biopsy specimen or tissue from resected tumor not used for diagnostic purposes) and a blood sample for tumor molecular profiling.
• Solid cancers include any of the following surgically resectable cancers: colorectal cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, breast cancer (either hormone receptor positive, HER2-positive or negative, or triple-negative breast cancer), pancreatic cancer, liver cancer, and melanoma. Curative therapy, whether surgery, radiation therapy, or adjuvant chemotherapy, must be completed per National Comprehensive Cancer Network (NCCN) guidelines.
• Must be willing to agree to initiation of development of personalized YE-NEO-001 vaccine.
• Treatment Phase:
• No evidence of disease (NED) at first assessment post multi-modality therapy (ie, surgery and/or radiation therapy and/or chemotherapy). Subjects treated with definitive radiation therapy are considered NED if they have no evidence of cancer growth on the first and second surveillance CT scans. Subjects who have disease recurrence prior to the start of the vaccination process are also eligible if no satisfactory alternative treatment options are available or if subject has refused all other available therapies.
• Must have received \< 6 months of SoC therapy.
• Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
• ECOG performance status of 0 to 2.
• Must be willing to provide blood samples prior to the start of treatment on this study for exploratory analyses.
• If cancer recurs while on treatment on this study, must be willing to provide a tumor biopsy specimen for exploratory analyses, if considered safe by the Investigator.
• Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• Agreement to practice effective contraception for female subjects with child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non-sterile male subjects must agree to use a condom for up to 4 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, IUDs, and abstinence.

You may not qualify if:

• Pre-treatment Phase: Tissue Procurement and Development of Vaccine
• \. Unable or unwilling to attend required study visits and return for adequate follow-up, as required by this protocol.
• Treatment Phase:
• Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
• Active autoimmune disease requiring systemic immunosuppressive treatment within 4 weeks prior to enrollment on this study (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma, ankylosing spondylitis, scleroderma, multiple sclerosis). A history of inactive autoimmune disease or autoimmune disease not requiring systemic immunosuppressive therapy within 4 weeks prior to study enrollment is allowed.
• History of organ transplant requiring immunosuppression.
• History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
• Inadequate organ function, evidenced by the following laboratory results:
• ANC \< 1,000 cells/mm\^3.
• Platelet count \< 75,000 cells/mm\^3.
• Uncorrectable grade 3 anemia (hemoglobin \< 8 g/dL).
• Total bilirubin \> ULN (unless the subject has documented Gilbert's syndrome).
• AST (SGOT) or ALT (SGPT) \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases).
• Alkaline phosphatase levels \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases, or \> 10 × ULN in subjects with bone metastases).
• Serum creatinine \> 2.0 mg/dL or 177 μmol/L.

Sponsors & Collaborators

• NantBioScience, Inc.: lead

Study Sites (1)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, 90245, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms; Squamous Cell Carcinoma of Head and Neck; Melanoma; Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 12, 2018
• Study Start: August 10, 2018
• Primary Completion: March 18, 2025
• Study Completion: March 18, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

US (1)