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JSB462

Phase 2

Prostatic Cancer, Castration-Resistant | Small molecule | Oncology |Novartis AG|Last Updated: May 1, 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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment138
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07047118A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)PHASE2 ACTIVE NOT_RECRUITING 138 — — Jul 3, 2025May 14, 2028May 1, 202646 United States, Australia +13
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Study Endpoints
Primary Endpoints
Prostate Specific Antigen 50 (PSA50) Rate
From date of randomization till 30 days safety fup, assessed up to approximately 30 months

Prostate Specific Antigen 50 (PSA50) Rate is defined as the proportion of participants who achieve a ≥50% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between

Incidence rate of adverse events (AEs)
From date of randomization till 30 days safety fup, assessed up to approximately 30 months

The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.

Number of participants with dose adjustments
From date of randomization till 30 days safety fup, assessed up to approximately 30 months

The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.

Duration of exposure to study treatment
From date of randomization till 30 days safety fup, assessed up to approximately 30 months

Dose interruptions, dose reductions, drug discontinuations, dose intensity, and duration of exposure to study treatment (all study drugs).

Secondary Endpoints
Radiographic Progression Free Survival (rPFS)
From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 41 months
Overall Survival (OS)
From date of randomization until date of death from any cause, assessed up to approximately 41 months
Incidence rate of adverse events (AEs)
From date of randomization until date of death from any cause, assessed up to approximately 41 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTALJSB462 100 mg QD + AAA617 7.4 GBq Q6W
Arm 2EXPERIMENTALJSB462 300 mg QD + AAA617 7.4 GBq Q6W
Arm 3ACTIVE_COMPARATORAAA617 7.4 GBq Q6W
Interventions
NameTypeDescription
JSB462DRUGAdministered orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision
AAA617DRUGadministered at 7.4 GBq intravenously every 6 weeks for up to 6 doses, unless there is disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites46

Key Inclusion Criteria: * Adult male participants with histologically and/or cytologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible. * An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade ≤2. * At least 1 bon...

Countries:United StatesAustraliaAustriaCanadaChinaCzechiaFranceGermanyIsraelItalyNetherlandsSingaporeSouth KoreaSpainTaiwan
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07047118Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT07047118studyFirstPostDate: changed