Clinical Trials List
Protocol Number20230239
NCT Number(ClinicalTrials.gov Identfier)NCT07213674
Active
2025-11-01 - 2031-07-31
Phase III
Not yet recruiting1
Recruiting4
A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/04/10
Investigators and Locations
Co-Principal Investigator
- Chuan-Shu Chen Division of Urology
- 林雁婷 Division of Radiology
- Cheng-Kuang Yang Division of Urology
- 張瓈文 Division of Urology
- 楊哲瑞 Division of Urology
- 裘坤元 Division of Urology
- Cheng-Che Chen Division of Urology
- 蔡世傳 Division of Nuclear Medicine
- Jian-Ri Li Division of Urology
- 梅承恩 Division of Emergency Medicine
- 王樹吉 Division of Urology
- 賴谷順 Division of Urology
- Chia-Yen Lin Division of Urology
- 張家程 Division of Urology
- 洪晟鈞 Division of Urology
- 楊涵中 Division of Urology
- JU-CHUAN HU Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Hong-Cheng Gan 無
- Yung-Chang Lin 無
- 黃文冠 無
- PO-HUNG LIN 無
- 吳俊德 無
- Yung-Chia Kao 無
- Feng-Yuan Liu 無
- 余紹銘 無
- 張境夫 無
- I-hung Shao 無
- 沈鼎文 無
- See-Tong Pang 無
- Po-Jung Su 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳宗哲 無
- FU-JEN HSUEH 無
- Yu-Chieh Tsai 無
- Jih-Hsiang Lee 無
- 徐偉勛 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 阮雍順 無
- Tsung-Jang Yeh 無
- Ching-Chia Li 無
- 張顥瀚 無
- Tsu-Ming Chien 無
- Hsiang Ying Lee 無
- Hung-Lung Ke 無
- 盧嘉文 無
- Jeng-Shiun Du 無
- Sheng-Chen Wen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wen-Pin Su
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic Castration-resistant Prostate Cancer
Objectives
This is a randomized, multicenter, open-label phase 3 trial comparing the efficacy and safety of xaluritamig plus abiraterone versus docetaxel, cabazitaxel, or abiraterone chosen by the trial administrator in chemotherapy-naïve mCRPC participants.
Eligible participants will be randomly assigned in a 1:1 ratio to receive:
• Xaluritamig plus abiraterone (experimental group)
• Docetaxel, cabazitaxel, or abiraterone (control group) as selected by the trial administrator. Randomization will be stratified based on the following criteria:
• Prior treatment with docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC) (yes or no)
• Presence of liver metastases (yes or no)
• Prior treatment with prostate-specific cell membrane antigen (PSMA) radioligand (yes/no)
• Intended treatment with docetaxel, cabazitaxel, or abiraterone.
The proportion of participants intended to receive abiraterone is expected to be approximately 15%.
This trial includes a 28-day screening period, a treatment period, a safety follow-up (SFU) period, and a long-term follow-up (LTFU) period. The trial is expected to last a total of approximately 82 months, starting with randomization from the first participant, followed by a recruitment period of approximately 22 months and treatment and follow-up of 60 months.
Test Drug
Frozen Crystal Injection
Injection
Injection
Lumps
Lumps
Lumps
Injection
Injection
Lumps
Lumps
Lumps
Active Ingredient
xaluritamig (AMG 509)
Docetaxel
Cabazitaxel
Abiraterone acetate
abiraterone acetate
Abiraterone Acetate
Docetaxel
Cabazitaxel
Abiraterone acetate
abiraterone acetate
Abiraterone Acetate
Dosage Form
243
270
270
110
110
110
270
270
110
110
110
Dosage
0.1 mg, 0.5 mg, 0.75 mg
20 mg/mL, 4ml
10 mg/mL, 6ml (60mg/6ml )
250 mg
20 mg/mL, 4ml
10 mg/mL, 6ml (60mg/6ml )
250 mg
Endpoints
•整體存活期 (OS)
Inclution Criteria
Inclusion Criteria:
Participant has provided informed consent before initiation of any study-specific activities/procedures.
Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
Participant must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.
Metastatic castration-resistant prostate cancer (mCRPC) with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days before enrollment.
Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria:
Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimum start value is 2.0 ng/mL.
Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.
Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scan (as per the 2+2 PCWG3-modified RECIST 1.1 criteria).
Participants must have had prior orchiectomy and/or ongoing androgen-deprivation therapy (ADT) and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L).
Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required.
Participants intended to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Adequate organ function.
Participant has provided informed consent before initiation of any study-specific activities/procedures.
Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
Participant must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.
Metastatic castration-resistant prostate cancer (mCRPC) with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days before enrollment.
Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria:
Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimum start value is 2.0 ng/mL.
Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.
Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scan (as per the 2+2 PCWG3-modified RECIST 1.1 criteria).
Participants must have had prior orchiectomy and/or ongoing androgen-deprivation therapy (ADT) and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L).
Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required.
Participants intended to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Adequate organ function.
Exclusion Criteria
Exclusion Criteria:
Disease Related:
Participants with a history of central nervous system (CNS) metastases.
Unresolved toxicities from prior antitumor therapy not having resolved to CTCAE version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.
Prior/Concomitant Therapy:
Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
Prior disease progression on or intolerance to abiraterone.
Prior treatment with any chemotherapy regimen in the mCRPC setting and/or > 6 cycles of docetaxel treatment in the mHSPC setting.
Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment with the following exceptions:
Androgen receptor pathway inhibitors (ARPIs; enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment.
Androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotrophin releasing hormone [LHRH/GnRH] analogue [agonist/antagonist]) is permitted.
Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment.
Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment.
Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities.
Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy.
Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment.
Prior CD3-directed therapy.
Disease Related:
Participants with a history of central nervous system (CNS) metastases.
Unresolved toxicities from prior antitumor therapy not having resolved to CTCAE version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.
Prior/Concomitant Therapy:
Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
Prior disease progression on or intolerance to abiraterone.
Prior treatment with any chemotherapy regimen in the mCRPC setting and/or > 6 cycles of docetaxel treatment in the mHSPC setting.
Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment with the following exceptions:
Androgen receptor pathway inhibitors (ARPIs; enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment.
Androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotrophin releasing hormone [LHRH/GnRH] analogue [agonist/antagonist]) is permitted.
Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment.
Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment.
Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities.
Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy.
Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment.
Prior CD3-directed therapy.
The Estimated Number of Participants
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Taiwan
60 participants
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Global
750 participants
