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ASV AGEN2017+ QS-21 Stimulon adjuvant

Phase 1

Solid Tumor, Adult | Monoclonal antibody | Oncology |Agenus Inc.|Last 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

Clinical trial landscape

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 used for?

ASV AGEN2017+ QS-21 Stimulon adjuvant is an investigational monoclonal antibody being developed for the treatment of solid tumors in adults. It is currently in Phase 1 clinical development, with one completed trial evaluating its immunogenicity in patients with adult solid tumors.

Who makes ASV AGEN2017+ QS-21 Stimulon adjuvant?

ASV AGEN2017+ QS-21 Stimulon adjuvant is being developed by Agenus Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AGEN. The company is conducting clinical research on this investigational therapy for oncology applications.

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

ASV AGEN2017+ QS-21 Stimulon adjuvant is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and immunogenicity in patients with solid tumors.

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

ASV AGEN2017+ QS-21 Stimulon adjuvant has one completed clinical trial registered under NCT03673020, titled "Phase 1a Study to Evaluate Immunogenicity of ASV®". This Phase 1 study enrolled 3 adult patients with solid tumors in the United States and was not randomized or blinded.

Is ASV AGEN2017+ QS-21 Stimulon adjuvant the same as ASV?

Yes, ASV AGEN2017+ QS-21 Stimulon adjuvant is also known as ASV. The clinical trial NCT03673020 refers to the drug as ASV® in its title, indicating that ASV is an alternative name for this investigational monoclonal antibody being developed by Agenus Inc.