Recent Updates
Recently added Catalysts

Synchrotope TA2M

Phase 1

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

Synchrotope TA2M development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2004

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Synchrotope TA2M clinical trials

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Synchrotope TA2M

What is Synchrotope TA2M used for?

Synchrotope TA2M is being studied for the treatment of melanoma, specifically skin melanoma. It was evaluated in a Phase 1 trial in patients with Stage IV melanoma. It is an investigational therapy and is not an approved treatment.

Who is developing Synchrotope TA2M?

Synchrotope TA2M is being developed by MannKind Corporation, which trades under the ticker MNKD. The company is the sponsor of the clinical program for this monoclonal antibody in melanoma.

What phase is Synchrotope TA2M in?

Synchrotope TA2M is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The program enrolled 26 patients in total.

What clinical trials is Synchrotope TA2M in?

Synchrotope TA2M was studied in the completed Phase 1 trial NCT00023647, titled Vaccine Therapy in Treating Patients With Stage IV Melanoma. The trial enrolled 26 patients in the United States and included adults 18 years and older.

Is Synchrotope TA2M FDA approved?

Synchrotope TA2M is not approved. It is an investigational monoclonal antibody that has completed a single Phase 1 trial in Stage IV melanoma, and no active trials are ongoing.