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doxorubicin-GnRH agonist conjugate AEZS-108

Phase 1

Prostate Cancer | Small molecule | Oncology |COSCIENS Biopharma Inc.|Last Updated: Jul 11, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

doxorubicin-GnRH agonist conjugate AEZS-108 · 1 trial · 4 indications

Phase 1 1
NCT01240629Doxorubicin-GnRH Agonist Conjugate AEZS-108 in Treating Patients With Metastatic Hormone-Resistant Prostate CancerProstate Cancer
COMPLETED43 Analytics
PHASE1COMPLETED
Doxorubicin-GnRH Agonist Conjugate AEZS-108 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Prostate Cancer
NCT0124062943
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Study Endpoints

Primary Endpoints

Clinical benefit defined as non-progression with no dose-limiting toxicity or other toxicity requiring termination of treatment
At 3 months up to 24 months

Secondary Endpoints

Time to overall disease progression
Up to 24 months
Response for patients with measurable disease based on the Response Evaluation Criteria in Solid Tumors (RECIST)
At 3 months up to 24 months
To assess the prostate specific antigen (PSA) response rate in patients treated with AN-152
At 3 months up to 24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm IEXPERIMENTALPatients receive doxorubicin-GnRH agonist conjugate AEZS-108 intravenously (IV) over 2 hours once every 21 days (21 days = 1 cycle). Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Interventions

NameTypeDescription
laboratory biomarker analysisOTHERCorrelative study
questionnaire administrationOTHERCorrelative study
doxorubicin-GnRH agonist conjugate AEZS-108DRUGGiven IV
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Eligibility Criteria

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

Inclusion * Histologically or cytologically confirmed prostate cancer * Measurable disease on computer tomography (CT) scan or evaluable disease with an elevated prostate specific antigen (PSA) * Documented progression on (a) at least one prior hormone treatment, which must have incorporated lutein...

Countries:United States
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Competitive Landscape -Prostate Cancer 252 trials

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Eli Lilly and CompanyLLY9PHASE3Abemaciclib, Abiraterone, Prednisone or Prednisolone
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
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BioNTech SE Sponsored ADRBNTX1PHASE3BNT324, Docetaxel, Prednisone/prednisolone
Telix Pharmaceuticals Limited Sponsored ADRTLX2PHASE368Ga-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
Xencor, Inc.XNCR1PHASE2vudalimab
Kyntra Bio, Inc.KYNB2PHASE2FG-3246
IDEAYA Biosciences, Inc.IDYA3PHASE1IDE-161, Pembrolizumab
Arcus Biosciences, Inc.RCUS2PHASE2Atezolizumab, Tocilizumab, Etrumadenant
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