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pVAXrcPSAv53l

Phase 1

Prostate Cancer | Monoclonal antibody | Oncology |Cellectis S.A.|Trials Updated: Mar 17, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

pVAXrcPSAv53l clinical trials

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 413 trials

Top 20 of 55 competitors

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Eli Lilly and CompanyLLY9PHASE3Abemaciclib, PNT2002, LY4101174, PSMA-62, LY4052031
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Novartis AG Sponsored ADRNVS34PHASE3Lutetium Lu 177 Vipivotide Tetraxetan, Gallium Ga 68 Gozetotide, gallium gozetotide, AAA817, Luxdegalutamide
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Sanofi SA Sponsored ADRSNY2PHASE3Docetaxel, Cabazitaxel
Lantheus Holdings IncLNTH4PHASE3LNTH-2401
BayerBAYRY15PHASE3Darolutamide, BAY3546828
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Monte Rosa Therapeutics, Inc.GLUE2PHASE2MRT-2359
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