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ASV AGEN2017+ QS-21 Stimulon adjuvant

Phase 1

Solid Tumor, Adult | Monoclonal antibody | Oncology |Agenus Inc.|Trials Updated: Dec 2, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment3

FDA Designations

No designations recorded

ASV AGEN2017+ QS-21 Stimulon adjuvant clinical trials

ASV AGEN2017+ QS-21 Stimulon adjuvant · 1 trial · 1 indication

Phase 1 1
NCT03673020Phase 1a Study to Evaluate Immunogenicity of ASV®Solid Tumor, Adult
COMPLETED3 Analytics
PHASE1COMPLETED
Phase 1a Study to Evaluate Immunogenicity of ASV®
Solid Tumor, AdultUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Treatment-Emergence Adverse Events (Safety and Tolerability)
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.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ASV® AGEN2017EXPERIMENTALASV® AGEN2017 + QS-21 Stimulon® Adjuvant Vaccine

Interventions

NameTypeDescription
ASV® AGEN2017 + QS-21 Stimulon® adjuvantBIOLOGICALNeoantigen Vaccine
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Signed, written informed consent. 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 melanom...

Countries:United States
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Frequently asked questions about ASV AGEN2017+ QS-21 Stimulon adjuvant

What is ASV AGEN2017+ QS-21 Stimulon adjuvant?

ASV AGEN2017+ QS-21 Stimulon adjuvant is an investigational monoclonal antibody therapeutic being developed by Agenus Inc. for the treatment of adult patients with solid tumors. It combines the ASV AGEN2017 antibody component with the QS-21 Stimulon adjuvant, a formulation intended to be evaluated in oncology settings.

What is ASV AGEN2017+ QS-21 Stimulon adjuvant used for?

ASV AGEN2017+ QS-21 Stimulon adjuvant is being studied for use in adults with solid tumors. Its only recorded clinical study enrolled patients with solid tumors, and the program remains in early clinical development rather than approved clinical use.

Who makes ASV AGEN2017+ QS-21 Stimulon adjuvant?

Agenus Inc., which trades under the ticker AGEN, is the developer of ASV AGEN2017+ QS-21 Stimulon adjuvant. The company is responsible for the investigational monoclonal antibody program and its QS-21 Stimulon adjuvant combination.

What phase is ASV AGEN2017+ QS-21 Stimulon adjuvant in?

ASV AGEN2017+ QS-21 Stimulon adjuvant is in Phase 1 development. It is investigational and has not been approved for commercial use. The program's single recorded trial was a Phase 1a study that has since been completed.

What clinical trials is ASV AGEN2017+ QS-21 Stimulon adjuvant in?

ASV AGEN2017+ QS-21 Stimulon adjuvant was evaluated in one clinical trial, NCT03673020, titled a Phase 1a Study to Evaluate Immunogenicity of ASV. That trial enrolled 3 adult patients with solid tumors in the United States and is now completed, with no active trials currently listed.