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MAGE-A3 ASCI

Phase 1

Bladder Cancer | Monoclonal antibody | Oncology |GSK plc|Last Updated: Feb 4, 2015

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

MAGE-A3 ASCI · 1 trial · 1 indication

Phase 1 1
NCT01498172BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) PatientsBladder Cancer
COMPLETED23 Analytics
PHASE1COMPLETED
BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) Patients
Bladder CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability
6 months

Secondary Endpoints

Flow cytometric analysis of type and number of immune cell types in urine
6 months
Measurement of titers of antibodies against recMAGE-A3 in serum
6 months
Assessment of disease recurrence by control cystoscopy
6 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NMIBC at intermediate risk of progressionEXPERIMENTAL -
NMIBC at high risk of progressionEXPERIMENTAL -
NMIBC at low risk of progressionEXPERIMENTAL -

Interventions

NameTypeDescription
MAGE-A3 ASCIBIOLOGICAL5 doses every 3 weeks
BCGBIOLOGICAL1 intravesical dose /week for 6 weeks
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Eligibility Criteria

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

Inclusion Criteria: * Male or female patient with histological confirmation of NMIBC * Full recovery from surgery (TUR) from 1 to 6 weeks * Karnofsky performance status of 60% or more * Laboratory parameters for vital functions should be in the normal range * Women of childbearing potential must us...

Countries:Switzerland
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Frequently asked questions about MAGE-A3 ASCI

What is MAGE-A3 ASCI used for in bladder cancer?

MAGE-A3 ASCI is an investigational antigen-specific cancer immunotherapeutic being studied for the treatment of non-muscle invasive bladder cancer (NMIBC). It is designed to be used in combination with BCG therapy to modulate the immune response in patients with this condition.

What does MAGE-A3 ASCI target?

MAGE-A3 ASCI targets the MAGE-A3 tumor antigen, which is expressed on various cancer cells. The therapy is designed to stimulate the immune system to recognize and attack cells presenting this antigen, potentially leading to an anti-tumor immune response.

Who is developing MAGE-A3 ASCI?

MAGE-A3 ASCI is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is investigating this therapy as a potential treatment option for bladder cancer.

What phase is MAGE-A3 ASCI in?

MAGE-A3 ASCI is in Phase 1 clinical development. It is an investigational drug that has not been approved by regulatory authorities. The therapy is currently being evaluated in early-stage clinical trials to assess its safety and preliminary efficacy.

What clinical trials is MAGE-A3 ASCI in?

MAGE-A3 ASCI has been studied in one completed Phase 1 clinical trial, identified as NCT01498172. This trial evaluated the combination of BCG with recMAGE-A3 plus AS15 ASCI in patients with non-muscle invasive bladder cancer. The trial enrolled 23 participants and was conducted in Switzerland.

Is MAGE-A3 ASCI the same as recMAGE-A3?

MAGE-A3 ASCI is also known as recMAGE-A3 when combined with the AS15 adjuvant system. The clinical trial NCT01498172 refers to the therapy as recMAGE-A3 + AS15 ASCI, indicating that MAGE-A3 ASCI is the antigen-specific cancer immunotherapeutic component of this combination.