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History of Changes for Study: NCT03673020
Phase 1a Study to Evaluate Immunogenicity of ASV
Latest version (submitted December 1, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 13, 2018 None (earliest Version on record)
2 October 31, 2018 Recruitment Status, Study Status, Contacts/Locations, Arms and Interventions, Study Description and Oversight
3 May 18, 2019 Study Status
4 July 30, 2019 Contacts/Locations and Study Status
5 March 19, 2020 Arms and Interventions, Contacts/Locations, Study Description, Study Status, Study Identification, Eligibility and Outcome Measures
6 April 24, 2020 Study Status and Contacts/Locations
7 June 8, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 May 19, 2021 Study Status
9 December 1, 2021 Recruitment Status and Study Status
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Study NCT03673020
Submitted Date:  September 13, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: C-610-01
Brief Title: Phase 1a Study to Evaluate Immunogenicity of ASV
Official Title: Phase 1a First-in-Human Study of Safety and Tolerability of ASV™ AGEN2017 With QS-21 Stimulon® Adjuvant as a Single Agent in Subjects With Solid Tumor at Risk of Relapse Undergoing Observation as SOC Following Complete Surgical Resection
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2018
Overall Status: Not yet recruiting
Study Start: October 2018
Primary Completion: January 2020 [Anticipated]
Study Completion: June 2020 [Anticipated]
First Submitted: September 11, 2018
First Submitted that
Met QC Criteria:
September 13, 2018
First Posted: September 17, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
September 13, 2018
Last Update Posted: September 17, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Agenus Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This is an open-label Phase 1a First-in-Human Study to determine Safety and Tolerability of ASV™ AGEN2017 with QS-21 Stimulon® Adjuvant as a Single Agent in Subjects With Tumors at Risk of Relapse Undergoing Observation as Standard of Care Following Complete Surgical Resection.
Detailed Description: This is a Phase 1a study to evaluate neoantigen vaccine, AutoSynVax (ASV) AGEN2017 in subjects with resected solid tumors, no evidence of disease (NED), and with an estimated life expectancy of ≥12 months from the time tissue has been submitted for vaccine manufacture. A minimum of 3 subjects will be enrolled to received every two weeks subcutaneous injection of AGEN2017 + QS-21 adjuvant.
Open or close this module Conditions
Conditions: Solid Tumor, Adult
Keywords: Vaccine
Solid Tumor
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 3 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: ASV™ AGEN2017
ASV™ AGEN2017 + QS-21 Stimulon® Adjuvant Vaccine
Biological: ASV™ AGEN2107 + QS-21 Stimulon® adjuvant
Neoantigen Vaccine
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of Treatment-Emergence Adverse Events (Safety and Tolerability)
[ Time Frame: 1 Year ]

Assessed by monitoring the frequency, duration, and severity of drug-related AEs by completing physical examinations and clinical evaluations; evaluating changes in vital signs; and laboratory blood and urine sample evaluations.
Secondary Outcome Measures:
1. Vaccine-induced cellular Response
[ Time Frame: 1 Year ]

T-cell response to tumor-specific neo-epitopes contained in the vaccine (cytokine release assay)
2. Time of recurrence
[ Time Frame: 1 Year ]

Interval from the date of first dose of investigational, agent until the earliest date of cancer recurrence, as determined by investigator assessment of objective radiographic disease assessments, or death due to any cause if occurring sooner than recurrence.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Signed, written informed consents to allow transfer of tumor tissue and blood for production of vaccine, and to receive treatment.
  2. Age ≥18 years.
  3. Diagnosis of solid cancer that has been completely resected, NED, and eligible for observation only as SOC yet remain at risk of relapse per Investigator discretion. These include subjects diagnosed with malignant melanoma, non-small cell lung cancer, bladder cancer, colorectal cancer, breast cancer, renal cancer, head and neck cancer, cervical cancer, and soft tissue sarcoma.
  4. Life expectancy ≥12 months from the time of consent for tissue procurement for vaccine production.
  5. Available fresh tissue from surgical excision. If fresh tissue is not available, formalin-fixed paraffin-embedded archival tissue may be used. The modality of the biopsy (e.g., endobronchial ultrasound, bronchoscopic, computed-tomography-guided needle biopsy) is not specified; however, core biopsy and fine needle aspiration are acceptable as long as the biopsy can be prepared as a cell block in paraffin-embedded tissue.
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  7. Adequate bone marrow function, as measured from studies of peripheral blood (absolute neutrophil count ≥1,500/mm3, absolute lymphocyte count ≥500/mm3, platelet count 50,000/mm3, hemoglobin >8.0 mg/dL).
  8. Adequate cardiac function (New York Heart Association class ≤II).
  9. Female subjects of childbearing potential must have a negative serum pregnancy test at the screening and pretreatment visits, and prior to first dose of study medication. Non-childbearing potential (other than by medical reasons) is defined as 1 of the following:
    1. ≥45 years of age and amenorrheic for >1 year by self-report.
    2. Amenorrheic for >2 years without a hysterectomy and oophorectomy, and follicle-stimulating hormone value in the postmenopausal range upon screening evaluation.
    3. Status post-hysterectomy, -oophorectomy, or -tubal ligation. If of childbearing potential, female subjects must be willing to use adequate birth control during the study, starting with the screening visit through 120 days after the last dose of study therapy.

    Male subjects with a female partner(s) of childbearing potential must agree to use a condom throughout the trial, starting with the screening visit through 120 days after the last dose of study therapy. Male subjects with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.

    Note: Abstinence is acceptable for both female and male subjects if this is the subject's established and preferred contraception method.

  10. Subject is willing and able to comply with the requirements of the protocol.

Exclusion Criteria:

  1. Subjects must not have received anticancer medications or investigational drugs within the following intervals before first dose of study drug:
    1. ≤14 days for chemotherapy, targeted small molecule therapy, anticancer hormone therapy, or radiation therapy, with the following exceptions:
      • Bisphosphonates and denosumab are permitted.
      • Novel imaging agents that have Phase 1 safety data and have not demonstrated therapeutic activity are permitted.
      • Physiologic steroid replacement for adrenal insufficiency (e.g., <10 mg prednisone per day) is permitted.
      • Prophylactic use of inhaled or topical corticosteroid or short course of intravenous systemic corticosteroid (≤3 days) for radiographic procedures is permitted.
      • Use of physiologic corticosteroid replacement therapy must be approved by the medical monitor.
    2. ≤28 days for prior cancer immunotherapy.
    3. ≤28 days for prior monoclonal antibody used for anticancer therapy, with the exception of denosumab.
    4. ≤7 days for immunosuppressive treatment for any reason. Systemic corticosteroids are not allowed except as defined above.
    5. e. ≤28 days before first dose of study drug for all other investigational study drugs or devices.
  2. Diagnosis of clinically significant immunodeficiency (as defined by the principal investigator), or actively receiving or potentially needing any form of immunosuppressive therapy within 7 days prior to the first dose of study drug until the end of the trial.
  3. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator or medical monitor.
  4. Uncontrolled intercurrent illness, including but not limited to uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or social situations that would limit compliance with study requirements in the opinion of the treating investigator or medical monitor.
  5. History of intolerance or allergic reactions attributed to compounds of similar chemical or biologic composition to AGEN2017 or QS-21 adjuvant.
  6. Women who are pregnant or breastfeeding.
Open or close this module Contacts/Locations
Central Contact Person: Agenus Study Team
Telephone: 781.674.4648
Email: agen2017@Agenusbio.com
Study Officials: Waldo Ortuzar, MD
Study Director
Agenus Inc.
Locations: United States, Florida
School of Medicine at the University of Miami
Miami, Florida, United States, 33136
Contact:Contact: Yvonne Dinh 305-243-9899 y.dinh@med.miami.edu
Contact:Principal Investigator: Breelyn Wilky, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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