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Synchrotope TA2M

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00023647Vaccine Therapy in Treating Patients With Stage IV MelanomaPHASE1 COMPLETED 26 — — Jul 1, 2000Nov 1, 2002Jul 10, 20121 United States
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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 — 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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Competitive Landscape -Melanoma 127 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK6PHASE3Intismeran autogene, Pembrolizumab, pembrolizumab, Pembrolizumab Berahyaluronidase alfa
Bristol-Myers Squibb CompanyBMY7PHASE3Nivolumab, Nivolumab + Relatlimab, rHuPH20, Relatlimab, relatlimab+nivolumab
Regeneron Pharmaceuticals, Inc.REGN8PHASE3Fianlimab, Cemiplimab, Pembrolizumab, fianlimab, cemiplimab
Pfizer Inc.PFE4PHASE3Encorafenib, Binimetinib, Pembrolizumab, PF-08046049, PF-07799933
IDEAYA Biosciences, Inc.IDYA4PHASE3Darovasertib, IDE196, Crizotinib, Pembrolizumab, Ipilimumab
Iovance Biotherapeutics IncIOVA6PHASE3Lifileucel plus Pembrolizumab, Pembrolizumab with Optional Crossover Period, Lifileucel, LN-145/LN-144, Cyclophosphamide
Replimune Group, Inc.REPL5PHASE3Vusolimogene Oderparepvec, Nivolumab, Pembrolizumab, Single-agent chemotherapy, RP1
Amgen Inc.AMGN1PHASE3ABP 206, Nivolumab
Immunocore Holdings Plc Shs Sponsored American Depositary Shares Repr 1 ShIMCR3PHASE3Tebentafusp, Brenetafusp, Nivolumab
Immatics N.V.IMTX2PHASE3IMA203, nivolumab plus relatlimab, lifileucel, pembrolizumab, ipilimumab
Aura Biosciences IncAURA4PHASE3Bel-sar
Novartis AG Sponsored ADRNVS6PHASE2LXH254, LTT462, Trametinib, Ribociclib, DYP688
IO Biotech, Inc.IOBT2PHASE3IO102-IO103, Pembrolizumab, Pembrolizumab KEYTRUDA
Erasca, Inc.ERAS1PHASE3Naporafenib, Dacarbazine, Temozolomide, Trametinib
AstraZeneca PLCAZN3PHASE2Ceralasertib, Durvalumab, AZD6750, rilvegostomig, Trastuzumab deruxtecan
Eikon Therapeutics, Inc.EIKN2PHASE2EIK1001, Pembrolizumab, Association atezolizumab + BDB001 + RT
Moderna, Inc.MRNA1PHASE2mRNA-4157, Pembrolizumab
Genmab A/S Sponsored ADRGMAB2PHASE2Acasunlimab, Pembrolizumab, GEN1042, Cisplatin, Carboplatin
Agenus Inc.AGEN1PHASE2Botensilimab, Balstilimab
ImmunityBio IncIBRX1PHASE2N-803 + Pembrolizumab
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