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Synchrotope TA2M

Phase 1

Melanoma (Skin) | Monoclonal antibody | Oncology |MannKind Corporation|Last Updated: Jul 10, 2012

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

Synchrotope TA2M · 1 trial · 1 indication

Phase 1 1
NCT00023647Vaccine Therapy in Treating Patients With Stage IV MelanomaMelanoma (Skin)
COMPLETED26 Analytics
PHASE1COMPLETED
Vaccine Therapy in Treating Patients With Stage IV Melanoma
Melanoma (Skin)Unlock trial analytics

Study Endpoints

Primary Endpoints

Frequency of adverse events assessed by complete blood count, blood chemistry, polymerase chain reaction, physical examination and urinalysis
Individual 96-hour infusion periods on days 0, 14, 28 and 42 and on day 56

Secondary Endpoints

Change in magnitude of antigen-specific cytotoxic t-lymphocyte in peripheral blood mononuclear cells
Day 0 (pre-study), last day of individual 96-hour infusion periods (days 4, 17, 31 and 45) and on day 56
Assessment of delayed-type hypersensitivity to intradermal injections 24 hours after injection
Days 1, 29 and 57
Change in size of target lesions by x-ray computed tomography before (day 0) and after (day 56)treatment
Change from pre-study (day 0) to day 56
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Synchrotope TA2M, 800 microgramsEXPERIMENTALTyrosinase peptides, 800 micrograms
Synchrotope TA2M, 200 microgramsEXPERIMENTALTyrosinase peptides, 200 micrograms
Synchrotope TA2M, 400 microgramsEXPERIMENTALTyrosinase peptides, 400 micrograms

Interventions

NameTypeDescription
Synchrotope TA2MBIOLOGICALCancer Vaccine, Immunotherapy
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Eligibility Criteria

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

INCLUSION CRITERIA - Patient must meet the following during the screening and baseline visits: 1. The patients or their legally acceptable representative must give signed informed consent for participation in the study before any study procedure is performed. 2. Patients must be 18 years of age or ...

Countries:United States
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Frequently asked questions about Synchrotope TA2M

What is Synchrotope TA2M used for?

Synchrotope TA2M is an investigational monoclonal antibody being developed for the treatment of melanoma, a type of skin cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.

What does Synchrotope TA2M target?

Synchrotope TA2M is a monoclonal antibody, a type of therapy designed to bind to specific proteins involved in disease. However, its specific molecular target has not been disclosed in available information, so the exact mechanism of action is not publicly detailed.

Who makes Synchrotope TA2M?

Synchrotope TA2M is being developed by MannKind Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol MNKD. The company is responsible for advancing this investigational therapy through clinical trials.

What phase is Synchrotope TA2M in?

Synchrotope TA2M is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory bodies. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.

What clinical trials is Synchrotope TA2M in?

Synchrotope TA2M has been studied in one clinical trial, identified as NCT00023647, titled "Vaccine Therapy in Treating Patients With Stage IV Melanoma." This Phase 1 study was completed in the United States and enrolled 26 participants aged 18 years and older.

Is Synchrotope TA2M the same as a vaccine?

Synchrotope TA2M is a monoclonal antibody, not a vaccine. Although the clinical trial NCT00023647 was titled "Vaccine Therapy," the drug itself is classified as a monoclonal antibody, which is a different type of therapeutic agent from a vaccine.