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P501-AS15 vaccine

Phase 1

Neoplasms, Prostate | Monoclonal antibody | Oncology |GSK plc|Last Updated: Jun 2, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

P501-AS15 vaccine · 1 trial · 1 indication

Phase 1 1
NCT00148928Safety & Activity of P501-AS15 Vaccine as a First-line Treatment for Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSANeoplasms, Prostate
COMPLETED25 Analytics
PHASE1COMPLETED
Safety & Activity of P501-AS15 Vaccine as a First-line Treatment for Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSA
Neoplasms, Prostate
NCT0014892825
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Study Endpoints

Primary Endpoints

Vaccine-related or possibly vaccine-related Grade 3 or 4 adverse event: a. Any Grade 4 toxicity: fatigue (including lethargy, asthenia, malaise) must have a duration of at least 24 hours. b. Any Grade 3 toxicity with a duration of at least 24 hours
During the study
Clinical PSA response

Secondary Endpoints

a. For patients who present a PSA response: The duration of PSA response, The duration of PSA control, The duration of log PSA response.
During the study
b. Humoral immune response induced by P501-AS15 vaccine: Anti-CPC seropositivity. Anti-P501 seropositivity.
At all points during treatment as specified in the study schedule
c. Cellular immune response induced by P501-AS15 vaccine. Frequency of in vitro cellular immune response to CPC P501.
At all points during treatment as specified in the study schedule
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Interventions

NameTypeDescription
P501-AS15 vaccineBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexMALE
Healthy VolunteersNo
Study Sites8

Inclusion criteria: * Male, * Aged between 18 and 75 years, inclusive, * Histologically or cytologically proven adenocarcinoma of the prostate before the initiation of therapy of the primary tumor, * Radical prostatectomy before progression of disease by rising PSA was established, * Primary tumor ...

Countries:BelgiumFrance
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Frequently asked questions about P501-AS15 vaccine

What is P501-AS15 vaccine used for?

P501-AS15 vaccine is an investigational cancer vaccine being studied for the treatment of prostate neoplasms. It was evaluated in a Phase 1 clinical trial as a first-line treatment for patients with hormone-sensitive prostate cancer who show rising PSA levels. The vaccine is intended for use in the oncology therapeutic area.

Who makes P501-AS15 vaccine?

P501-AS15 vaccine is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company sponsored the clinical development of this investigational vaccine for prostate cancer.

What phase is P501-AS15 vaccine in?

P501-AS15 vaccine is in Phase 1 clinical development. The single Phase 1 trial has been completed, and the vaccine remains investigational. It has not been approved by regulatory authorities and is still in the early stages of clinical testing.

What clinical trials is P501-AS15 vaccine in?

P501-AS15 vaccine has been studied in one completed Phase 1 clinical trial, registered as NCT00148928. The trial evaluated the safety and activity of the vaccine as a first-line treatment for patients with hormone-sensitive prostate cancer who show rising PSA. The study enrolled 25 male participants aged 18 years and older in Belgium and France.

Is P501-AS15 vaccine the same as P501-AS15?

P501-AS15 vaccine is the full name of the investigational product, and P501-AS15 refers to the same vaccine. The vaccine is also known by the name P501-AS15 in clinical trial documentation. It is an investigational cancer vaccine being developed for prostate cancer.