Clinical Trials List
Protocol NumberCJSB462B12201
NCT Number(ClinicalTrials.gov Identfier)NCT07047118
Active
2025-05-01 - 2029-03-06
Phase II
Recruiting2
A phase II, randomized, open-label, multicenter trial is being conducted to evaluate the use of JSB462 (luxdegalutamide) in combination with lutetium (177Lu) vipivotide tetraxetan in adult male patients with prostate-specific cell membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
-
Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
-
Sponsor
Novartis Taiwan Co., Ltd.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/08/03
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chun-Te Wu
Co-Principal Investigator
- PO-HUNG LIN Division of Urology
- 黃意方 Division of Urology
- Hong-Cheng Gan Division of Urology
- Rita cheng Division of Urology
- Jing-Ren Tseng Division of Urology
- See-Tong Pang Division of Urology
- 沈鼎文 Division of Urology
- I-hung Shao Division of Urology
- Yung-Chang Lin Division of Urology
- Kai-Jie Yu Division of Urology
- Kung-Chu Ho Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
PSMA-positive metastatic castration-resistant prostate cancer who had previously received at least one ARPI
Objectives
This Phase II trial aims to evaluate the efficacy and safety of 100 mg and 300 mg once daily (QD) JSB462 (also known as luxdegalutamide) + lutetium (177Lu) vipivotide tetraxetan (hereinafter referred to as AAA617) compared to AAA617 monotherapy (control group) in mCRPC participants who have previously received at least one androgen receptor signaling inhibitor (ARPI) and 0-2 courses of taxane therapy, and to select the recommended dose for Phase III concomitant treatment. To this end, this trial will assess overall efficacy, safety, tolerability, and pharmacokinetics (PK) data in randomly assigned participants.
Test Drug
JSB462
Active Ingredient
Luxdegalutamide
Dosage Form
Tablets
Dosage
100 mg
Endpoints
• Efficacy: The PSA50 ratio is defined as the proportion of participants whose prostate-specific antigen (PSA) has decreased by ≥50% since baseline at any time point, confirmed by a second PSA measurement (at least 3 weeks apart) and whose PSA has not worsened during this period.
• Safety: Type, frequency, and severity of adverse events (AEs) as determined by the Common Adverse Event Evaluation Criteria (CTCAE) version 5.0, as well as changes in laboratory values, vital signs, and electrocardiogram (ECG).
• Tolerability: Interruption of investigational treatment (all investigational drugs), dose reduction, discontinuation of treatment, dose intensity, and duration of exposure.
• Safety: Type, frequency, and severity of adverse events (AEs) as determined by the Common Adverse Event Evaluation Criteria (CTCAE) version 5.0, as well as changes in laboratory values, vital signs, and electrocardiogram (ECG).
• Tolerability: Interruption of investigational treatment (all investigational drugs), dose reduction, discontinuation of treatment, dose intensity, and duration of exposure.
Inclution Criteria
1. Adult male participants with histologically and/or cytologically confirmed prostate cancer. Participants with mixed histological (neuroendocrine) findings are ineligible.
2. East Coast Cancer Clinical Research Consortium (ECOG) Performance Status (PS) ≤2.
3. Baseline CT, MRI, or bone scan imaging showing at least one bone or organ metastasis, acquired ≤28 days after the start of trial treatment.
4. Participants must be confirmed as eligible with a positive gallium (68Ga) gozetotide PET/CT scan by the trial commissioner.
5. Participants must have previously received at least one second-generation ARPI for metastatic/advanced disease.
6. Participants are permitted to have received up to two courses of taxane therapy.
7. Participants eligible for PARPi and/or immune checkpoint inhibitors (as determined by the trial administrator based on local testing) must have previously received these therapies to be eligible to participate.
2. East Coast Cancer Clinical Research Consortium (ECOG) Performance Status (PS) ≤2.
3. Baseline CT, MRI, or bone scan imaging showing at least one bone or organ metastasis, acquired ≤28 days after the start of trial treatment.
4. Participants must be confirmed as eligible with a positive gallium (68Ga) gozetotide PET/CT scan by the trial commissioner.
5. Participants must have previously received at least one second-generation ARPI for metastatic/advanced disease.
6. Participants are permitted to have received up to two courses of taxane therapy.
7. Participants eligible for PARPi and/or immune checkpoint inhibitors (as determined by the trial administrator based on local testing) must have previously received these therapies to be eligible to participate.
Exclusion Criteria
1. No prior experience with any RLT (approved or experimental) treatment is permitted.
2. No prior experience with protein-degrading compounds targeting the androgen receptor (AR) is permitted.
2. No prior experience with protein-degrading compounds targeting the androgen receptor (AR) is permitted.
The Estimated Number of Participants
-
Taiwan
4 participants
-
Global
130 participants
