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pVAXrcPSAv53l

Phase 1

Prostate Cancer | Monoclonal antibody | Oncology |Pulse Biosciences, Inc|Last Updated: Mar 17, 2014

Success Probability
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Market & Valuation
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical trial landscape

pVAXrcPSAv53l · 1 trial · 1 indication

Phase 1 1
NCT00859729Dose Finding Study of a DNA Vaccine Delivered With Intradermal Electroporation in Patients With Prostate CancerProstate Cancer
COMPLETED15 Analytics
PHASE1COMPLETED
Dose Finding Study of a DNA Vaccine Delivered With Intradermal Electroporation in Patients With Prostate Cancer
Prostate Cancer
NCT0085972915
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Study Endpoints
Primary Endpoints
Assess the feasibility and safety of escalating doses of pVAXrcPSAv53l DNA vaccine, administered intradermally in combination with electroporation in patients with relapse of prostate cancer.
From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
Secondary Endpoints
Assess the safety and functionality of the DERMA VAX™ in vivo electroporation DNA vaccine delivery system.
From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
Evaluate the PSA-specific immune response induced by the vaccine.
From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
Identify an anti-tumor effect of the vaccine.
From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort IEXPERIMENTAL50 µg DNA/dose, 3 patients
Cohort IIEXPERIMENTAL150 µg DNA/dose, 3 patients
Cohort IIIEXPERIMENTAL400 µg DNA/dose, 3 patients
Cohort IVEXPERIMENTAL1000 µg DNA/dose, 3 patients
Cohort VEXPERIMENTALOptimal dose to be determined, 6 patients
Interventions
NameTypeDescription
pVAXrcPSAv53l (DNA encoding rhesus PSA)BIOLOGICAL5 doses, 4 weeks apart
DERMA VAX™ intradermal DNA delivery systemDEVICEin vivo electroporation is applied after each DNA injection
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Eligibility Criteria
Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male patients. Age \>18 years. * HLA-A\*0201 positive. * Histologically confirmed prostate cancer. * Minimum two (2) and maximum four (4) years after treatment with curative or salvage radiotherapy. * Serum testosterone within normal range. * Increasing PSA from a previous ref...

Countries:Sweden
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Competitive Landscape -Prostate Cancer 256 trials

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Merck & Co., Inc.MRK6PHASE3Ifinatamab deruxtecan, Docetaxel, Prednisone
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Johnson & JohnsonJNJ21PHASE3Apalutamide, Androgen Deprivation Therapy
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Amgen Inc.AMGN7PHASE3Xaluritamig, Abiraterone, Enzalutamide, Cabazitaxel
Novartis AG Sponsored ADRNVS27PHASE3177Lu-PSMA-617, 68Ga-PSMA-11, ARDT, ADT
Exelixis, Inc.EXEL4PHASE3Cabozantinib, Atezolizumab, Abiraterone, Enzalutamide, Prednisone
Candel Therapeutics, Inc.CADL3PHASE3Aglatimagene besadenovec, valacyclovir
Bristol-Myers Squibb CompanyBMY2PHASE3BMS-986365, Enzalutamide, Abiraterone, Docetaxel, Predinsone/Prednisolone
BioNTech SE Sponsored ADRBNTX1PHASE3BNT324, Docetaxel, Prednisone/prednisolone
Telix Pharmaceuticals Limited Sponsored ADRTLX3PHASE368Ga-PSMA-11
Sanofi SA Sponsored ADRSNY2PHASE3abiraterone, Docetaxel
Regeneron Pharmaceuticals, Inc.REGN4PHASE2REGN2810, Degarelix, Leuprolide, Docetaxel
Veracyte, Inc.VCYT2PHASE2Darolutamide, Zoladex, Zoladex LA, Decapeptyl sustained release, Depo-Eligard
Lantheus Holdings IncLNTH3PHASE3Undisclosed
Kyntra Bio, Inc.KYNB2PHASE2FG-3246
IDEAYA Biosciences, Inc.IDYA3PHASE1IDE-161, Pembrolizumab
Xencor, Inc.XNCR1PHASE2vudalimab
Arcus Biosciences, Inc.RCUS2PHASE2Atezolizumab, Tocilizumab, Etrumadenant
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