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YS5 antibody

Phase 1

Prostate Cancer | Monoclonal antibody | Oncology |United Therapeutics Corporation|Last Updated: Mar 17, 2026

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05245006PET Imaging Study of 89Zr-DFO-YS5 in Men With Prostate CancerPHASE1 ACTIVE NOT_RECRUITING 30Mar 18, 2022Jul 31, 2027Mar 17, 20261 United States
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Study Endpoints
Primary Endpoints
Optimal time point for imaging using 89Zr-DFO-YS5 PET post-injection (Cohort A)
Up to 7 days

For Cohort A, the optimal time point will be selected based on optimal maximun Standardized uptake value (SUVmax) of metastatic lesions, and ratio of SUVmax to blood pool. Due to the limited samples, the investigator will use all available lesions without considering the location of the lesions or the possible intra-correlation of the lesions from the same participant.

Optimal antibody dose for imaging using 89Zr-DFO-YS5 PET (Cohort B)
Up to 7 days

For Cohort B, the optimal dose of antibody will be selected based on the optimal SUVmax of metastatic lesions, and ratio of SUVmax to blood pool. Due to the limited samples, the investigator will use all available lesions without considering the location of the lesions or the possible intra-correlation of the lesions from the same participant.

Proportion of participants with metastatic lesions accurately detected in mCRPC using 89Zr-DFO-YS5 PET (sensitivity) (Cohort C)
Up to 24 months

Sensitivity is the probability that a test will indicate disease among those with the actual disease: True Positive / (True Positive + False Negative). Lesions will be graded on a semi-quantitative scale ranging from 1-5 as is common for 89Zr-antibody human imaging studies (1 = no uptake, 2 = probably no uptake, 3 = equivocal, 4 = probably positive, 5 = definitely positive). Using as a cut-off to 4 or 5 on the semi-quantitative scale, the sensitivity of 89Zr-DFO-YS5 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan. The sensitivity estimate will be based on lesion level without considering the location of the lesions or the possible intra-correlation of the lesions from the same patient.

Median SUVmax (Cohort C)
Up to 24 months

The median and range of SUVmax across all metastatic lesions per participant will be descriptively reported using mediastinal blood pool and normal organ as background uptake values will be reported with range of SUVmax.

Average SUVmax (SUVmax-ave) (Cohort C)
Up to 24 months

The average SUVmax-ave across all metastatic lesions per participant will be descriptively reported using mediastinal blood pool and normal organ as background uptake values for all cohorts will be reported with 95% confidence intervals

Secondary Endpoints
Proportion of participants with treatment-related Adverse Events
Up to 3 weeks after last dose administration, approximately 35 days
Average organ uptake of 89Zr-DFO-YS5 (Cohort C)
Up to 24 months
Intra-tumoral uptake of 89Zr-DFO-YS5 by tumor type (Cohort C)
Up to 24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Cohort A: 89Zr-DFO-YS5EXPERIMENTALParticipants receive one dose of 89Zr-DFO-YS5 up to 3 millicurie (mCi), and undergo a whole body PET performed at 1-4 hours, approximately 20-28 hours, 48-96 hours, and 120-168 hours post injection for up to 4 scans total. The optimized scan time will be used for imaging in cohorts B and C. Participants have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression.
Cohort B: 89Zr-DFO-YS5, YS5 antibodyEXPERIMENTALParticipants receive either a 20mg or 50mg dose of YS5 prior to imaging and administration of one dose of up to 3 millicurie (mCi) 89Zr-DFO-YS5 and then complete a single whole body PET scan at the optimal time determined in Cohort A. The optimal dose of unmodified YS5 antibody will be used in the following cohorts C \& D. Participants have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression.
Cohort C: 89Zr-DFO-YS5, Optimal dose YS5 antibodyEXPERIMENTALParticipants receive optimal dose of YS5 antibody prior to imaging and administration of one dose of up to 3 millicurie (mCi) 89Zr-DFO-YS5 and then complete a single whole body PET scan at the optimal time determined in Cohort A. Participants have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression.
Interventions
NameTypeDescription
89Zr-DFO-YS5DRUG3 mCi will be administered intravenously
YS5 antibodyBIOLOGICAL20 or 50 mg administered intravenously
Positron Emission Tomography (PET)/Computerized tomography (CT)PROCEDUREImaging which combines a CT scan and a PET scan
Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI)PROCEDUREImaging which combines an MRI scan and a PET scan
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Participants must have histologically or cytologically confirmed metastatic, castration resistant prostate cancer (mCRPC). 2. Age \>=18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Karnofsky \>60%). 4. Demonstrates adequate organ function as def...

Countries:United States
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Competitive Landscape -Prostate Cancer 259 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK7PHASE3Pembrolizumab, Enzalutamide, Ifinatamab deruxtecan, Docetaxel, Prednisone
AstraZeneca PLCAZN20PHASE3olaparib, abiraterone, Saruparib, Abiraterone, Darolutamide
Pfizer Inc.PFE12PHASE3Talazoparib with enzalutamide, PF-06821497, Docetaxel, Enzalutamide, Leuprolide Open Label
Johnson & JohnsonJNJ21PHASE3Apalutamide, Androgen Deprivation Therapy, Niraparib, Abiraterone, Prednisone
Eli Lilly and CompanyLLY9PHASE3Abemaciclib, Abiraterone, Prednisone or Prednisolone, -PNT2002, Enzalutamide
Amgen Inc.AMGN7PHASE3Xaluritamig, Abiraterone, Enzalutamide, Cabazitaxel, Docetaxel
Novartis AG Sponsored ADRNVS28PHASE3177Lu-PSMA-617, 68Ga-PSMA-11, ARDT, ADT, AAA617
Exelixis, Inc.EXEL4PHASE3Cabozantinib, Atezolizumab, Abiraterone, Enzalutamide, Prednisone
Candel Therapeutics, Inc.CADL3PHASE3Aglatimagene besadenovec + valacyclovir, aglatimagene besadenovec, valacyclovir, aglatimagene 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, 177Lu-TLX591, Enzalutamide, Abiraterone, Docetaxel
Sanofi SA Sponsored ADRSNY2PHASE3abiraterone, Docetaxel, Cabazitaxel
Regeneron Pharmaceuticals, Inc.REGN4PHASE2REGN2810, Degarelix, Leuprolide, Docetaxel, BPX-601
Veracyte, Inc.VCYT2PHASE2Darolutamide, Zoladex, Zoladex LA, Decapeptyl sustained release, Depo-Eligard
Kyntra Bio, Inc.KYNB2PHASE2FG-3246, FOR46, Enzalutamide, Pegfilgrastim
Lantheus Holdings IncLNTH3PHASE3Undisclosed
IDEAYA Biosciences, Inc.IDYA3PHASE1IDE-161, Pembrolizumab, IDE034, IDE574, Fulvestrant
Xencor, Inc.XNCR1PHASE2vudalimab
GSK plc Sponsored ADRGSK2PHASE1GSK5471713, GSK5458514
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05245006studyFirstPostDate: changed