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Df-IAB2M

Phase 2

Prostate Cancer | Unknown | Oncology |Telix Pharmaceuticals Limited|Last Updated: Feb 13, 2020

Target and mechanism

ModalityUnknown

Also known as [89Zr]Df-IAB2M

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

Df-IAB2M · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT02349022Comparison of PET With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-ProstatectomyProstate Cancer
COMPLETED19 Analytics
PHASE2COMPLETED
Comparison of PET With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-Prostatectomy
Prostate Cancer
NCT0234902219
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Study Endpoints

Primary Endpoints

Compare sensitivity/specificity/PPV/NPV/Accuracy of [111In] capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT as confirmed by pathology
6 weeks
Determine the safety of [89Zr]Df-IAB2M PET in patients with metastatic prostate cancer.
Day 1 (Infusion Day) through Day 7

To assess the safety of a single dose of of \[89Zr\]Df-IAB2M

Secondary Endpoints

Assess the safety of a single dose of [89Zr]-Df-IAB2M
Day 1 through Day 13
Histopathologic correlation of PSMA expression and prostate cancer from surgical or biopsy specimens with uptake of [89Zr]-Df-IAB2M on PET/CT
Day 1 through Day 13
Compare the concordant and discordant rate for positive/negative areas of uptake between [111In]-Capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT using pathology for ground truth of disease status
Day 1 through Day 13
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
[89Zr]Df-IAB2MEXPERIMENTALA single intravenous infusion of 2.5 mCi of \[89Zr\]Df-IAB2M in a mass dose of 10 mg.

Interventions

NameTypeDescription
[89Zr]Df-IAB2MRADIATION -
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Eligibility Criteria

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

Inclusion Criteria: Patients must meet ALL criteria listed below for entry: * Age ≥ 18 years * Signed, written IRB-approved informed consent * Patients newly diagnosed with biopsy-proven prostate cancer, thought to be a candidate for prostatectomy after standard diagnostic evaluation (e.g. chest x...

Countries:United States
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Competitive Landscape -Prostate Cancer 252 trials

Top 20 of 52 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN19PHASE3olaparib, abiraterone
Merck & Co., Inc.MRK6PHASE3Ifinatamab deruxtecan, Docetaxel, Prednisone
Pfizer Inc.PFE12PHASE3Talazoparib with enzalutamide
Johnson & JohnsonJNJ20PHASE3Apalutamide, Androgen Deprivation Therapy
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
Bristol-Myers Squibb CompanyBMY2PHASE3BMS-986365, Enzalutamide, Abiraterone, Docetaxel, Predinsone/Prednisolone
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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