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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07047118
Registration number
NCT07047118
Ethics application status
Date submitted
20/05/2025
Date registered
2/07/2025
Date last updated
10/09/2025
Titles & IDs
Public title
A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
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Scientific title
A Phase II, Randomized, Open-label, Multi-center Study of JSB462 (Luxdegalutamide) in Combination With Lutetium (177Lu) Vipivotide Tetraxetan in Adult Male Patients With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)
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Secondary ID [1]
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2024-520155-24-00
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Secondary ID [2]
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CJSB462B12201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostatic Cancer, Castration-Resistant
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JSB462
Treatment: Drugs - AAA617
Experimental: Arm 1 - JSB462 100 mg QD + AAA617 7.4 GBq Q6W
Experimental: Arm 2 - JSB462 300 mg QD + AAA617 7.4 GBq Q6W
Active comparator: Arm 3 - AAA617 7.4 GBq Q6W
Treatment: Drugs: JSB462
Administered 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
Treatment: Drugs: AAA617
administered 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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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Prostate Specific Antigen 50 (PSA50) Rate
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Assessment method [1]
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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
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Timepoint [1]
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From date of randomization till 30 days safety fup, assessed up to approximately 30 months
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Primary outcome [2]
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Incidence rate of adverse events (AEs)
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Assessment method [2]
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The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.
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Timepoint [2]
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From date of randomization till 30 days safety fup, assessed up to approximately 30 months
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Primary outcome [3]
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Number of participants with dose adjustments
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Assessment method [3]
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The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.
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Timepoint [3]
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From date of randomization till 30 days safety fup, assessed up to approximately 30 months
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Primary outcome [4]
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Duration of exposure to study treatment
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Assessment method [4]
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Dose interruptions, dose reductions, drug discontinuations, dose intensity, and duration of exposure to study treatment (all study drugs).
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Timepoint [4]
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From date of randomization till 30 days safety fup, assessed up to approximately 30 months
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Secondary outcome [1]
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Radiographic Progression Free Survival (rPFS)
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Assessment method [1]
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Radiographic Progression Free Survival (rPFS) is defined as the time between randomization and the first occurrence of disease progression (per PCWG3-modified RECIST 1.1 as assessed by the investigator) or death due to any cause
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Timepoint [1]
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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
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Overall Survival (OS) is defined as the time between randomization and death due to any cause
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Timepoint [2]
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From date of randomization until date of death from any cause, assessed up to approximately 41 months
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Secondary outcome [3]
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Incidence rate of adverse events (AEs)
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Assessment method [3]
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The analysis of adverse events and laboratory abnormalities will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.
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Timepoint [3]
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From date of randomization until date of death from any cause, assessed up to approximately 41 months
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Secondary outcome [4]
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Overall Response Rate (ORR)
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Assessment method [4]
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Overall Response Rate (ORR) is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) per PCWG3-modified RECIST 1.1 as assessed by the investigator
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Timepoint [4]
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From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 41 months
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Secondary outcome [5]
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Disease Control Rate (DCR)
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Assessment method [5]
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Disease Control Rate (DCR) is defined as the proportion of participants achieving a CR, PR or stable disease (SD) per PCWG3-modified RECIST 1.1 as assessed by the investigator
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Timepoint [5]
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From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 41 months
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Secondary outcome [6]
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Duration of Response (DOR)
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Assessment method [6]
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Duration of Response (DOR) is defined as the time between first documented CR/PR and disease progression or death due to any cause per PCWG3-modified RECIST 1.1 as assessed by the investigator
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Timepoint [6]
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From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 41 months
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Secondary outcome [7]
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Time to Response (TTR)
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Assessment method [7]
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Time to response (TTR) is defined as the time from randomization to the date of first documented CR or PR per PCWG3-modified RECIST 1.1 as assessed by the investigator
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Timepoint [7]
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From date of randomization until date of first documented Complete Response (CR) or Partial Response (PR), assessed up to approximately 41 months
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Secondary outcome [8]
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Time to soft tissue progression (TTSTP)
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Assessment method [8]
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Time to soft tissue progression (TTSTP) is defined as the time from randomization to the date of first documented radiographic soft tissue progression per PCWG3-modified RECIST 1.1 as assessed by the investigator
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Timepoint [8]
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From date of randomization until date of soft tissue radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 41 months
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Secondary outcome [9]
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Prostate Specific Antigen 90 (PSA90) Rate
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Assessment method [9]
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Prostate Specific Antigen 90 (PSA90) Rate is defined as the proportion of participants who achieve a =90% decrease in PSA from baseline at any timepoint, confirmed by a second PSA measurement =3 weeks without any PSA progression in between.
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Timepoint [9]
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From date of randomization till 30 days safety fup, assessed up to approximately 30 months
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Secondary outcome [10]
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Prostate Specific Antigen 30 (PSA30) Rate
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Assessment method [10]
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Prostate Specific Antigen 30 (PSA30) Rate is defined as the proportion of participants who achieve a =30% decrease from baseline at any timepoint, confirmed by a second PSA measurement =3 weeks without any PSA progression in between
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Timepoint [10]
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From date of randomization till 30 days safety fup, assessed up to approximately 30 months
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Secondary outcome [11]
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Prostate Specific Antigen 0 (PSA0) Rate
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Assessment method [11]
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Prostate Specific Antigen 0 (PSA0) Rate is defined as the proportion of participants who achieve a PSA level \<0.2 ng/ml at any timepoint after start of treatment, confirmed by a second PSA measurement =3 weeks without any PSA progression in between
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Timepoint [11]
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From date of randomization till 30 days safety fup, assessed up to approximately 30 months
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Secondary outcome [12]
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Duration of biochemical response (DBR)
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Assessment method [12]
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Duration of biochemical response (DBR) is defined as the time between the first date of PSA50 response and the date of PSA progression (an increase =25% in PSA and an absolute increase of =2 ng/mL above the NADIR confirmed by a second value =3 weeks later if there is PSA decline from baseline, or a =25% increase and a =2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline) or death due to any cause.
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Timepoint [12]
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From date of date of first PSA50 response until date of PSA progression or death from any cause, assessed up to approximately 41 months
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Secondary outcome [13]
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Time to first symptomatic skeletal event (TTSSE)
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Assessment method [13]
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Time to first symptomatic skeletal event (TTSSE) is defined as the date of randomization to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first
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Timepoint [13]
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From randomization until the first occurrence of a new symptomatic bone fracture, spinal cord compression, tumor-related orthopedic surgery, radiation therapy for bone pain, or death, assessed up to 41 months.
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Secondary outcome [14]
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Plasma concentrations of JSB462 and plasma concentrations of its metabolite ARV-767
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Assessment method [14]
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JSB462 pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels in JSB462 treatment arms.
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Timepoint [14]
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Day 1 of Cycles 1 and 2: Pre-dose/0hour and Post-dose 4hour +/- 1hour. Day 1 of Cycles 3 to 6: Pre-dose/0hour. End of Treatment Visit (EOT): through study treatment discontinuation, an average of 24 months. 1 cycle = 28 days.
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Secondary outcome [15]
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Concentrations of AAA617 in blood over time and PK parameters from blood radioactivity data
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Assessment method [15]
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AAA617 pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels in AAA617 treatment arm.
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Timepoint [15]
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Cycle 1: Day 1 (pre-dose/0hour, end of infusion (EOI), 1hour ±15minutes, 4hours ±30minutes), Day 2 (24hours ±2hours), Day 3 (48hours ±2hours), Day 8 (168hours ±12hours).Cycles 3 & 5: Day 1 (pre-dose/0hour, EOI), Day 3 (48hours ±2hours). 1 cycle=6 weeks.
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Secondary outcome [16]
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Area under the AAA617 concentration-time curve from time zero to the time of last quantifiable concentration (AUClast)
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Assessment method [16]
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Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUClast will be listed and summarized using descriptive statistics.
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Timepoint [16]
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Cycle 1: Day 1 (pre-dose/0hour, end of infusion (EOI), 1hour ±15minutes, 4hours ±30minutes), Day 2 (24hours ±2hours), Day 3 (48hours ±2hours), Day 8 (168hours ±12hours).Cycles 3 & 5: Day 1 (pre-dose/0hour, EOI), Day 3 (48hours ±2hours). 1 cycle=6 weeks.
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Secondary outcome [17]
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Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) of AAA617
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Assessment method [17]
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Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUCinf will be listed and summarized using descriptive statistics.
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Timepoint [17]
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Cycle 1: Day 1 (pre-dose/0hour, end of infusion (EOI), 1hour ±15minutes, 4hours ±30minutes), Day 2 (24hours ±2hours), Day 3 (48hours ±2hours), Day 8 (168hours ±12hours).Cycles 3 & 5: Day 1 (pre-dose/0hour, EOI), Day 3 (48hours ±2hours). 1 cycle=6 weeks.
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Secondary outcome [18]
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Observed maximum blood concentration (Cmax) of AAA617
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Assessment method [18]
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Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
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Timepoint [18]
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Cycle 1: Day 1 (pre-dose/0hour, end of infusion (EOI), 1hour ±15minutes, 4hours ±30minutes), Day 2 (24hours ±2hours), Day 3 (48hours ±2hours), Day 8 (168hours ±12hours).Cycles 3 & 5: Day 1 (pre-dose/0hour, EOI), Day 3 (48hours ±2hours). 1 cycle=6 weeks.
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Secondary outcome [19]
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Time of maximum observed blood concentration occurrence (Tmax) of AAA617
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Assessment method [19]
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Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Tmax will be listed and summarized using descriptive statistics.
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Timepoint [19]
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Cycle 1: Day 1 (pre-dose/0hour, end of infusion (EOI), 1hour ±15minutes, 4hours ±30minutes), Day 2 (24hours ±2hours), Day 3 (48hours ±2hours), Day 8 (168hours ±12hours).Cycles 3 & 5: Day 1 (pre-dose/0hour, EOI), Day 3 (48hours ±2hours). 1 cycle=6 weeks.
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Secondary outcome [20]
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Terminal elimination half-life (T1/2) of AAA617
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Assessment method [20]
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Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. The half-life will be listed and summarized using descriptive statistics.
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Timepoint [20]
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Cycle 1: Day 1 (pre-dose/0hour, end of infusion (EOI), 1hour ±15minutes, 4hours ±30minutes), Day 2 (24hours ±2hours), Day 3 (48hours ±2hours), Day 8 (168hours ±12hours).Cycles 3 & 5: Day 1 (pre-dose/0hour, EOI), Day 3 (48hours ±2hours). 1 cycle=6 weeks.
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Secondary outcome [21]
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Total systemic clearance for intravenous administration (CL) of AAA617
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Assessment method [21]
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Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. CL will be listed and summarized using descriptive statistics.
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Timepoint [21]
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Cycle 1: Day 1 (pre-dose/0hour, end of infusion (EOI), 1hour ±15minutes, 4hours ±30minutes), Day 2 (24hours ±2hours), Day 3 (48hours ±2hours), Day 8 (168hours ±12hours).Cycles 3 & 5: Day 1 (pre-dose/0hour, EOI), Day 3 (48hours ±2hours). 1 cycle=6 weeks.
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Secondary outcome [22]
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Volume of distribution during the terminal phase following intravenous elimination (Vz) of AAA617
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Assessment method [22]
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Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Vz will be listed and summarized using descriptive statistics.
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Timepoint [22]
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Cycle 1: Day 1 (pre-dose/0hour, end of infusion (EOI), 1hour ±15minutes, 4hours ±30minutes), Day 2 (24hours ±2hours), Day 3 (48hours ±2hours), Day 8 (168hours ±12hours).Cycles 3 & 5: Day 1 (pre-dose/0hour, EOI), Day 3 (48hours ±2hours). 1 cycle=6 weeks.
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Secondary outcome [23]
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Radiation absorbed doses in organs and tumors for AAA617
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Assessment method [23]
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The organ absorbed radiation dose (Gy/GBq) as well as the effective radiation dose (mSv/GBq) will be evaluated and summarized descriptively.
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Timepoint [23]
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Cycle 1: Day 1 (1-4 hours), Day 2 (24 hours ±6 hours), Day 3 (48 hours ±6 hours), Day 8 (168 hours ±24 hours). Cycle 3: Day 1 (1-4 hours), Day 3 (48 hours ±6 hours). Cycle 5b (fit patients): Day 1 (1-4 hours), Day 3 (48 hours ±6 hours). 1 cycle=6 weeks.
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Secondary outcome [24]
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Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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Assessment method [24]
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The PRO-CTCAE is a patient-reported outcomes measurement system developed by the National Cancer Institute as a companion to the CTCAE. It includes items covering participant-reported symptomatic adverse events (AEs) from the CTCAE. Each symptomatic AE concept has up to three items evaluating frequency, severity, or interference, focused on the study population and treatment regimens. Participants respond on a 5-point scale for each item: * Frequency: Never, Rarely, Occasionally, Frequently, Almost constantly * Severity: None, Mild, Moderate, Severe, Very severe * Interference: Not at all, A little bit, Somewhat, Quite a bit, Very much The past 7-day recall version is used, focusing on relevant symptoms like fatigue, diarrhea, and hot flashes.
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Timepoint [24]
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From date of randomization until date of death from any cause, assessed up to approximately 41 months
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Eligibility
Key inclusion criteria
Key
* 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 bone or visceral metastatic lesion present on baseline CT, MRI, or bone scan imaging obtained =28 days prior to initiation of study treatment.
* Participants must be [68Ga]Ga-PSMA-11 PET/CT scan positive and eligible as determined by the sponsor's central reader.
* Participant must have prior exposure to at least one second generation ARPI in the metastatic/advanced setting.
* Previous treatment with a maximum of 2 taxane regimens is allowed.
* Participants eligible for PARPi and/or immune checkpoint inhibitor (per local testing and according to investigator's judgement) are eligible to participate if they have previous exposure to this(these) therapy(ies).
Key
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior treatment with any RLT (approved or investigational) is not allowed
* Prior treatment with a protein degrader compound that targets AR is not allowed
Other protocol-defined inclusion/exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/07/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
11/12/2028
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Actual
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Sample size
Target
130
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Adelaide
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Recruitment hospital [2]
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Novartis Investigative Site - Melbourne
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Nebraska
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Country [2]
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Israel
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State/province [2]
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Haifa
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Country [3]
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0
Israel
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State/province [3]
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Jerusalem
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Country [4]
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Singapore
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State/province [4]
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Singapore
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + lutetium (177Lu) vipivotide tetraxetan (hereafter referred as AAA617) compared with AAA617 (control) in participants with metastatic Castration Resistant Prostate Cancer (mCRPC) with prior exposure to at least 1 Androgen Receptor Pathway Inhibitor (ARPI) and 0-2 taxane regimens and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and pharmacokinetic (PK) data from participants randomized in the study will be evaluated.
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Trial website
https://clinicaltrials.gov/study/NCT07047118
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Novartis Pharmaceuticals
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Address
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Country
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Phone
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1-888-669-6682
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Fax
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0
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07047118
Download to PDF