- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03673020
Phase 1a Study to Evaluate Immunogenicity of ASV®
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- School of Medicine at the University of Miami
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed, written informed consent.
- Age ≥18 years.
- 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.
- Life expectancy ≥12 months from the time of consent.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- 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).
- Adequate cardiac function (New York Heart Association class ≤II).
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:
- ≥45 years of age and amenorrheic for >1 year by self-report.
- Amenorrheic for >2 years without a hysterectomy and oophorectomy, and follicle-stimulating hormone value in the postmenopausal range upon screening evaluation.
- 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.
- Subject is willing and able to comply with the requirements of the protocol.
Exclusion Criteria:
Subjects must not have received anticancer medications or investigational drugs within the following intervals before first dose of study drug:
≤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.
- ≤28 days for prior cancer immunotherapy.
- ≤28 days for prior monoclonal antibody used for anticancer therapy, with the exception of denosumab.
- ≤7 days for immunosuppressive treatment for any reason. Systemic corticosteroids are not allowed except as defined above.
- e. ≤28 days before first dose of study drug for all other investigational study drugs or devices.
Note: Washout is applicable to the screening visit only, and not applicable prior to the first dose of study drug. Subjects are not to receive anti-cancer therapies from date of consent through the post treatment visit (end of treatment or final safety visit).
- 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.
- 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.
- 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.
- History of intolerance or allergic reactions attributed to compounds of similar chemical or biologic composition to AGEN2017 or QS-21 adjuvant.
- Women who are pregnant or breastfeeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ASV® AGEN2017
ASV® AGEN2017 + QS-21 Stimulon® Adjuvant Vaccine
|
Neoantigen Vaccine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 Year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- C-610-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Solid Tumor, Adult
-
Memorial Sloan Kettering Cancer CenterRecruitingSolid Tumor | Solid Tumor, Adult | Solid Tumor, Unspecified, AdultUnited States
-
Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRecruitingSolid Tumor | Solid Tumor, Adult | Solid Tumor, Unspecified, AdultUnited States, Puerto Rico
-
Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRecruitingSolid Tumor | Solid Tumor, Adult | Solid Tumor, Unspecified, AdultUnited States, Puerto Rico
-
Shenzhen Ionova Life Sciences Co., Ltd.Merck Sharp & Dohme LLCRecruitingCancer | Solid Tumor, Adult | Solid Carcinoma | Solid Tumor, Unspecified, Adult | Cancer Metastatic | Tumor, SolidUnited States
-
Partner Therapeutics, Inc.WithdrawnSolid Tumor | Solid Tumor, AdultUnited States
-
Invitae CorporationRecruitingCancer | Solid Tumor | Solid Tumor, AdultUnited States
-
Sairopa B.V.RecruitingMetastatic Solid Tumor | Solid Tumor, Adult | Refractory CancerUnited States, Moldova, Republic of
-
Institut CurieRecruitingChemotherapy Effect | Solid Tumor, Adult | Solid Tumor, ChildhoodFrance
-
New York Stem Cell Foundation Research InstituteStevens Institute of TechnologyRecruiting
-
JemincareNot yet recruiting