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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

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Hepatocellular Carcinoma
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Pancreatic Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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.
  • Official Title: 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.

Clinical Trial IDs

  • ORG STUDY ID: QUILT-2.025
  • NCT ID: NCT03552718

Conditions

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

Interventions

DrugSynonymsArms
YE-NEO-001YE-NEO-001 Injectable SuspensionExperimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001)

Purpose

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.

Detailed Description

      This is a phase 1 trial to evaluate the safety, the RP2D, and preliminary efficacy of a
      personalized neoepitope yeast-based vaccine, YE-NEO-001, in subjects who have completed
      potentially curative therapy for their type of solid cancer (eg, colorectal cancer, breast
      cancer, head and neck squamous cell carcinoma, melanoma) and would otherwise be entering a
      period of surveillance for recurrent disease.

      The study will be conducted in two parts: part 1 will involve dose escalation, and part 2
      will involve the expansion of the RP2D to further evaluate the safety of YE-NEO-001. In part
      2 of the study, dose expansion will occur when the RP2D has been determined. An additional 4
      subjects may be enrolled in part 2, for a total of up to 10 subjects at the RP2D.
    

Trial Arms

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

Eligibility Criteria

        Inclusion Criteria:

        Pre-treatment Phase: Tissue Procurement and Development of Vaccine

          1. Age ≥ 18 years old.

          2. Able to understand and provide a signed informed consent that fulfills the relevant
             IRB or IEC guidelines.

          3. 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.

          4. Must be willing to agree to initiation of development of personalized YE-NEO-001
             vaccine.

        Treatment Phase:

          1. 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.

          2. Must have received < 6 months of SoC therapy.

          3. Able to understand and provide a signed informed consent that fulfills the relevant
             IRB or IEC guidelines.

          4. ECOG performance status of 0 to 2.

          5. Must be willing to provide blood samples prior to the start of treatment on this study
             for exploratory analyses.

          6. 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.

          7. Ability to attend required study visits and return for adequate follow-up, as required
             by this protocol.

          8. 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.

        Exclusion Criteria:

        Pre-treatment Phase: Tissue Procurement and Development of Vaccine

        1. Unable or unwilling to attend required study visits and return for adequate follow-up,
        as required by this protocol.

        Treatment Phase:

          1. 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.

          2. 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.

          3. History of organ transplant requiring immunosuppression.

          4. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative
             colitis).

          5. Inadequate organ function, evidenced by the following laboratory results:

               1. ANC < 1,000 cells/mm^3.

               2. Platelet count < 75,000 cells/mm^3.

               3. Uncorrectable grade 3 anemia (hemoglobin < 8 g/dL).

               4. Total bilirubin > ULN (unless the subject has documented Gilbert's syndrome).

               5. AST (SGOT) or ALT (SGPT) > 2.5 × ULN (> 5 × ULN in subjects with liver
                  metastases).

               6. Alkaline phosphatase levels > 2.5 × ULN (> 5 × ULN in subjects with liver
                  metastases, or > 10 × ULN in subjects with bone metastases).

               7. Serum creatinine > 2.0 mg/dL or 177 μmol/L.

          6. Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or
             clinically significant (ie, active) cardiovascular disease, cerebrovascular
             accident/stroke, or myocardial infarction within 6 months prior to first study
             medication; unstable angina; congestive heart failure of New York Heart Association
             grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with
             uncontrolled hypertension should be medically managed on a stable regimen to control
             hypertension prior to study entry.

          7. Positive results of screening test for HIV.

          8. Current chronic daily treatment (continuous for > 3 months) with systemic
             corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone),
             excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic
             reaction or anaphylaxis in subjects who have known contrast allergies is allowed.

          9. Known hypersensitivity to any component of the study medication(s).

         10. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug
             reaction with the study treatment. Anti-androgen and anti-estrogen medications are
             allowed.

         11. Participation in an investigational drug study or history of receiving any
             investigational treatment within 30 days prior to initiation of treatment on this
             study, except for testosterone-lowering therapy in men with prostate cancer.

         12. Assessed by the Investigator to be unable or unwilling to comply with the requirements
             of the protocol.

         13. Concurrent participation in any interventional clinical trial.

         14. Pregnant and nursing women.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of treatment-emergent adverse events
Time Frame:19 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Recurrence rate
Time Frame:19 months
Safety Issue:
Description:The appearance of any lesion that is confirmed by biopsy (in subjects with no evidence of disease (NED) at the start of the treatment only)
Measure:Disease-free survival (DFS)
Time Frame:24 months
Safety Issue:
Description:The time from the date of first YE-NEO-001 treatment to the date of disease recurrence or death (any cause), whichever occurs first (in subjects with NED at the start of treatment only)
Measure:Overall survival (OS)
Time Frame:36 months
Safety Issue:
Description:The time from the date of first YE-NEO-001 treatment to the date of death (any cause) (in all subjects)
Measure:Progression-free survival (PFS)
Time Frame:24 months
Safety Issue:
Description:The time from the date of first YE-NEO-001 treatment to the date of disease progression or death (any cause), whichever occurs first (in all subjects)

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:NantBioScience, Inc.

Trial Keywords

  • solid tumors

Last Updated

April 9, 2019