Clinical Trials List
Protocol Number20230239
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
IQVIA
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Principal Investigator
Shian-Shiang Wang
Co-Principal Investigator
- Chia-Yen Lin Division of Urology
- 張家程 Division of Urology
- 林雁婷 Division of Urology
- Cheng-Kuang Yang Division of Urology
- 張瓈文 Division of Urology
- 楊哲瑞 Division of Urology
- 洪晟鈞 Division of Urology
- 楊涵中 Division of Urology
- JU-CHUAN HU
- Jian-Ri Li Division of Urology
- 裘坤元 Division of Urology
- Cheng-Che Chen Division of Urology
- 蔡世傳 Division of General Surgery
- Chuan-Shu Chen Division of Urology
- 梅承恩 Division of Emergency Medicine
- 王樹吉 Division of Urology
- 賴谷順 Division of Nuclear Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Kuan-Yu Wu 無
- 鍾秉軒 無
- Yuh-Shyan Tsai 無
- Che-Yuan Hu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 沈鼎文 無
- See-Tong Pang 無
- Po-Jung Su 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
- Hong-Cheng Gan 無
- Yung-Chang Lin 無
- 黃文冠 無
- PO-HUNG LIN 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jih-Hsiang Lee 無
- 徐偉勛 無
- 吳宗哲 無
- FU-JEN HSUEH 無
- Yu-Chieh Tsai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jeng-Shiun Du 無
- Sheng-Chen Wen 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
- 阮雍順 無
- Tsung-Jang Yeh 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
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
Overall Survival
Inclution Criteria
Inclusion Criteria
Participants must meet all of the following criteria to be eligible for inclusion in this trial:
101. Participants have provided subject consent before commencing any trial-specified activity or procedure.
102. At the time of signing the subject consent form, participants must be ≥18 years of age (or ≥ that age if the legal age in their country exceeds 18).
103. Participants must have histologically, pathologically, and/or cytologically confirmed adenocarcinoma of the prostate. Mixed histological types (e.g., adenocarcinoma with a neuroendocrine composition) are not permitted.
104. Participants must have mCRPC and have at least one metastatic lesion shown on a baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan within 28 days prior to enrollment.
105. Evidence of disease progression (PD), defined as one or more of the PCWG3 revised RECIST 1.1 criteria:
• Serum prostate-specific antigen (PSA) progression, defined as two consecutive PSA readings above the reference value measured at least one week prior. The minimum starting value is 2.0 ng/mL. Eligibility must be assessed locally.
• Soft tissue progression, defined as an increase of ≥20% in the sum of diameters (SOD) of all target lesions (short axis of nodular lesions and long axis of non-nodular lesions) compared to the minimum SOD since the start of treatment, or the appearance of one or more new lesions or significant worsening of existing non-target lesions.
• Bone disease progression, defined as the discovery of at least two new bone lesions on a bone scan (according to the 2+2 PCWG3 revised RECIST 1.1 criteria). 106. Participants must have previously undergone orchiectomy and/or are currently receiving androgen deprivation therapy (ADT), and their serum testosterone levels must be at castration concentrations (< 50 ng/dL or < 1.7 nmol/L).
107. Participants must have experienced worsening after treatment with one (only one) androgen receptor pathway inhibitor (ARPI) (enzalutamide, apalutamide, or darolutamide).
108. Participants scheduled to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel treatment for mHSPC.
109. East Coast Cancer Clinical Research Consortium (ECOG) performance status score of 0 or 1.
110. Sufficient organ function, defined as follows:
• Blood function (no blood transfusion or growth factor infusion within 14 days of screening and eligibility assessment):
− White blood cell count ≥ 2.5 x 10⁹/L, and absolute neutrophil count ≥ 1.5 x 10⁹/L
− Platelet count ≥ 100 x 10⁹/L
− Heme ≥ 9 g/dL (90 g/L)
• Kidney function:
− Estimated glomerular filtration rate calculated using the kidney disease diet adjustment formula ≥ 30 mL/min/1.73 m²
• Liver function:
− Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times the upper limit of normal (ULN) (≤ 5 times ULN for participants with liver involvement)
− Total bilirubin (TBL) ≤ 1.5 times ULN (≤ 2 times ULN for participants with liver involvement) • ULN (3 times). Participants with known Gilbert's syndrome are allowed a TBL ≤ 3 times ULN.
• Lung function:
- Baseline oxygen saturation (at rest and in room air) > 92%, no supplemental oxygen required.
• Cardiac function:
− Left ventricular ejection fraction > 50% (Only participants with a known history of heart disease, including myocardial infarction [MI], angina, coronary artery bypass surgery, angioplasty, or stent placement, are required to undergo echocardiography at screening.)
Life expectancy ≥ 12 weeks, as assessed by the treating physician.
Participants must meet all of the following criteria to be eligible for inclusion in this trial:
101. Participants have provided subject consent before commencing any trial-specified activity or procedure.
102. At the time of signing the subject consent form, participants must be ≥18 years of age (or ≥ that age if the legal age in their country exceeds 18).
103. Participants must have histologically, pathologically, and/or cytologically confirmed adenocarcinoma of the prostate. Mixed histological types (e.g., adenocarcinoma with a neuroendocrine composition) are not permitted.
104. Participants must have mCRPC and have at least one metastatic lesion shown on a baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan within 28 days prior to enrollment.
105. Evidence of disease progression (PD), defined as one or more of the PCWG3 revised RECIST 1.1 criteria:
• Serum prostate-specific antigen (PSA) progression, defined as two consecutive PSA readings above the reference value measured at least one week prior. The minimum starting value is 2.0 ng/mL. Eligibility must be assessed locally.
• Soft tissue progression, defined as an increase of ≥20% in the sum of diameters (SOD) of all target lesions (short axis of nodular lesions and long axis of non-nodular lesions) compared to the minimum SOD since the start of treatment, or the appearance of one or more new lesions or significant worsening of existing non-target lesions.
• Bone disease progression, defined as the discovery of at least two new bone lesions on a bone scan (according to the 2+2 PCWG3 revised RECIST 1.1 criteria). 106. Participants must have previously undergone orchiectomy and/or are currently receiving androgen deprivation therapy (ADT), and their serum testosterone levels must be at castration concentrations (< 50 ng/dL or < 1.7 nmol/L).
107. Participants must have experienced worsening after treatment with one (only one) androgen receptor pathway inhibitor (ARPI) (enzalutamide, apalutamide, or darolutamide).
108. Participants scheduled to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel treatment for mHSPC.
109. East Coast Cancer Clinical Research Consortium (ECOG) performance status score of 0 or 1.
110. Sufficient organ function, defined as follows:
• Blood function (no blood transfusion or growth factor infusion within 14 days of screening and eligibility assessment):
− White blood cell count ≥ 2.5 x 10⁹/L, and absolute neutrophil count ≥ 1.5 x 10⁹/L
− Platelet count ≥ 100 x 10⁹/L
− Heme ≥ 9 g/dL (90 g/L)
• Kidney function:
− Estimated glomerular filtration rate calculated using the kidney disease diet adjustment formula ≥ 30 mL/min/1.73 m²
• Liver function:
− Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times the upper limit of normal (ULN) (≤ 5 times ULN for participants with liver involvement)
− Total bilirubin (TBL) ≤ 1.5 times ULN (≤ 2 times ULN for participants with liver involvement) • ULN (3 times). Participants with known Gilbert's syndrome are allowed a TBL ≤ 3 times ULN.
• Lung function:
- Baseline oxygen saturation (at rest and in room air) > 92%, no supplemental oxygen required.
• Cardiac function:
− Left ventricular ejection fraction > 50% (Only participants with a known history of heart disease, including myocardial infarction [MI], angina, coronary artery bypass surgery, angioplasty, or stent placement, are required to undergo echocardiography at screening.)
Life expectancy ≥ 12 weeks, as assessed by the treating physician.
Exclusion Criteria
Exclusion Criteria
Participants are excluded from the trial if they meet any of the following criteria:
Disease-Related
201. Participants with a history of central nervous system (CNS) metastases.
•Note: Participants with asymptomatic and clinically stable dural metastases who have received treatment are eligible for the trial.
202. The toxicity of previous antitumor therapy has not been resolved to Grade 1 or the baseline of Commonly Used Terminology in Adverse Events (CTCAE) version 5.0, with exceptions for hair loss or stable and well-controlled toxicity, provided that both the trial administrator and the trial sponsor agree to allow inclusion in the trial.
Other Medical Conditions
203. A history of malignancy that may alter life expectancy or interfere with disease assessment. Participants with a history of malignancy who have received appropriate treatment and have been disease-free for more than 3 years are eligible. Participants with appropriate treatment for non-melanoma skin cancer or superficial bladder cancer are also eligible.
204. History of allergic reactions or acute allergic reactions to the investigational therapeutic ingredient or similar substances (participants with known allergies to docetaxel or polysorbate who intend to receive abiraterone are eligible). Participants with known contraindications to high-dose corticosteroids are also excluded from the trial. Participants with known allergies to docetaxel who intend to receive abiraterone are eligible.
205. History of active autoimmune disease requiring systemic treatment (excluding complementary therapies) within the past 2 years, or other illness requiring immunosuppressive therapy during the trial.
206. History or evidence of inflammatory bowel disease (ulcerative colitis or Crohn's disease), or other gastrointestinal disorders causing persistent nausea, vomiting, or diarrhea (defined as CTCAE ≥ Grade 2).
207. Evidence of interstitial lung disease or active non-infectious pneumonia, or poorly controlled asthma.
208. Recent history of arterial or venous thrombosis (e.g., stroke or transient ischemic attack, pulmonary embolism, or deep vein thrombosis); within 6 months and 3 months prior to the first dose of trial treatment, respectively.
Note: Participants with a recent history of venous thrombosis must maintain the same anticoagulant therapy for at least 28 days prior to the first dose of trial treatment.
209. As determined by the trial administrator, a resting electrocardiogram (ECG) showing poorly controlled and potentially reversible cardiac problems (e.g., unstable ischemia, poorly controlled symptomatic arrhythmia, congestive heart failure, Fredericia-corrected QT interval prolongation > 480 ms, electrolyte imbalance, etc.), or the participant having congenital QT prolongation syndrome.
210. Participants who have experienced myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association grade ≥ 2) within 12 months of the first dose of trial treatment, excluding ischemic or non-ST-segment elevation myocardial infarction, and whose condition has been controlled more than 6 months prior to the first dose of trial treatment and confirmed by a cardiologist, are eligible for the trial.
211. Known:
• Human Immunodeficiency Virus (HIV) infection (Participants infected with HIV who are receiving antiretroviral therapy and whose viral load is undetectable are eligible for inclusion, but viral reactivation must be monitored regularly during the trial treatment period),
• Hepatitis C infection (Participants who have achieved a stable viral response after antiretroviral therapy for hepatitis C are eligible for inclusion),
• Hepatitis B infection (Participants with hepatitis B surface antigen or core antibody who have achieved a sustained viral response after antiretroviral therapy are eligible for inclusion, but viral reactivation must be monitored regularly during the trial treatment period).
212. Participants currently receiving antiviral therapy and meeting the foregoing criteria are eligible for the trial, provided that the antiviral therapy will not cause significant drug interactions with the experimental treatment.
213. Participants must have a serious medical condition, including but not limited to poorly controlled hypertension, poorly controlled infection, contraindication to abiraterone, docetaxel, cabazitaxel (if applicable) or with unacceptable risks, or other significant comorbidities (including physical or mental illness/condition) that, in the assessment of the trial administrator, would impair participation or compliance.
214. Participants must have undergone a solid organ transplant.
215. Participants must have undergone major surgery within 4 weeks prior to the first dose of the experimental treatment. Placement of an artificial vascular graft is not considered a major surgery.
Previous/Current Concomitant Treatments
217. Participants must have previously received STEAP1 targeted therapy.
218. Participants must have experienced disease progression or intolerance to abiraterone treatment.
219. Participants must have previously received any chemotherapy regimen for mCRPC and/or received >6 cycles of docetaxel treatment for mHSPC.
220. Received any anticancer therapy, immunotherapy, or investigational drug within 4 weeks prior to the first dose of trial treatment, excluding androgen-suppressing therapies (e.g., luteinizing hormone-releasing hormone/gonadotropin-releasing hormone [LHRH/GnRH] analogs [agonists/antagonists]).
221. Received prostate-specific cell membrane antigen (PSMA) radioligand therapy (RLT) within 3 months of the first dose of trial treatment. Participants who received <2 cycles of PSMA RLT within 6 weeks of the first dose of trial treatment are also excluded.
222. Received radioactive seed therapy (radium-223) within 2 months of the first dose of trial treatment.
224. Received palliative radiation therapy within 2 weeks prior to the first dose of trial treatment. All radiation-related toxicities in the participant must have resolved.
225. Concurrently receiving cytotoxic chemotherapy, ARPI, immunotherapy, RLT, PARP inhibitors, biologics, or trial treatment.
Note: PARP inhibitor treatment can be received as long as more than 4 weeks have passed since the first dose of experimental treatment.
226. Received live virus and live attenuated vaccine treatment within 4 weeks prior to the first dose of experimental treatment.
Previously/currently participating in other clinical trials.
227. Currently receiving treatment with other experimental devices or drugs, or having completed treatment with other experimental devices or drugs less than 30 days ago. This does not apply to other experimental procedures or participation in observational studies.
Other exclusion criteria:
228. Participants who do not wish to avoid donating sperm during treatment, and participants whose partners are pregnant or of childbearing potential, who do not wish to abstain from sexual intercourse (avoiding heterosexual intercourse) or use contraception during treatment and for an additional 6 months after the last dose of xaluritamig, an additional 3 weeks after the last dose of abiraterone acetate, a 4-month period after the last dose of cabazitaxel, or a 4-month period after the last dose of docetaxel.
229 To the best of the participant's and the trial administrator's knowledge, the participant may be unable to complete all trial follow-ups or procedures as required by the trial plan, and/or cooperate with all required trial procedures (e.g., clinical outcome assessment).
230 Other clinically significant abnormalities, conditions, medical histories, or evidence (other than those listed above) that, in the opinion of the trial administrator or Amgen physician (if consulted), may jeopardize the participant's safety or affect trial assessment, procedures, or completion.
Participants are excluded from the trial if they meet any of the following criteria:
Disease-Related
201. Participants with a history of central nervous system (CNS) metastases.
•Note: Participants with asymptomatic and clinically stable dural metastases who have received treatment are eligible for the trial.
202. The toxicity of previous antitumor therapy has not been resolved to Grade 1 or the baseline of Commonly Used Terminology in Adverse Events (CTCAE) version 5.0, with exceptions for hair loss or stable and well-controlled toxicity, provided that both the trial administrator and the trial sponsor agree to allow inclusion in the trial.
Other Medical Conditions
203. A history of malignancy that may alter life expectancy or interfere with disease assessment. Participants with a history of malignancy who have received appropriate treatment and have been disease-free for more than 3 years are eligible. Participants with appropriate treatment for non-melanoma skin cancer or superficial bladder cancer are also eligible.
204. History of allergic reactions or acute allergic reactions to the investigational therapeutic ingredient or similar substances (participants with known allergies to docetaxel or polysorbate who intend to receive abiraterone are eligible). Participants with known contraindications to high-dose corticosteroids are also excluded from the trial. Participants with known allergies to docetaxel who intend to receive abiraterone are eligible.
205. History of active autoimmune disease requiring systemic treatment (excluding complementary therapies) within the past 2 years, or other illness requiring immunosuppressive therapy during the trial.
206. History or evidence of inflammatory bowel disease (ulcerative colitis or Crohn's disease), or other gastrointestinal disorders causing persistent nausea, vomiting, or diarrhea (defined as CTCAE ≥ Grade 2).
207. Evidence of interstitial lung disease or active non-infectious pneumonia, or poorly controlled asthma.
208. Recent history of arterial or venous thrombosis (e.g., stroke or transient ischemic attack, pulmonary embolism, or deep vein thrombosis); within 6 months and 3 months prior to the first dose of trial treatment, respectively.
Note: Participants with a recent history of venous thrombosis must maintain the same anticoagulant therapy for at least 28 days prior to the first dose of trial treatment.
209. As determined by the trial administrator, a resting electrocardiogram (ECG) showing poorly controlled and potentially reversible cardiac problems (e.g., unstable ischemia, poorly controlled symptomatic arrhythmia, congestive heart failure, Fredericia-corrected QT interval prolongation > 480 ms, electrolyte imbalance, etc.), or the participant having congenital QT prolongation syndrome.
210. Participants who have experienced myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association grade ≥ 2) within 12 months of the first dose of trial treatment, excluding ischemic or non-ST-segment elevation myocardial infarction, and whose condition has been controlled more than 6 months prior to the first dose of trial treatment and confirmed by a cardiologist, are eligible for the trial.
211. Known:
• Human Immunodeficiency Virus (HIV) infection (Participants infected with HIV who are receiving antiretroviral therapy and whose viral load is undetectable are eligible for inclusion, but viral reactivation must be monitored regularly during the trial treatment period),
• Hepatitis C infection (Participants who have achieved a stable viral response after antiretroviral therapy for hepatitis C are eligible for inclusion),
• Hepatitis B infection (Participants with hepatitis B surface antigen or core antibody who have achieved a sustained viral response after antiretroviral therapy are eligible for inclusion, but viral reactivation must be monitored regularly during the trial treatment period).
212. Participants currently receiving antiviral therapy and meeting the foregoing criteria are eligible for the trial, provided that the antiviral therapy will not cause significant drug interactions with the experimental treatment.
213. Participants must have a serious medical condition, including but not limited to poorly controlled hypertension, poorly controlled infection, contraindication to abiraterone, docetaxel, cabazitaxel (if applicable) or with unacceptable risks, or other significant comorbidities (including physical or mental illness/condition) that, in the assessment of the trial administrator, would impair participation or compliance.
214. Participants must have undergone a solid organ transplant.
215. Participants must have undergone major surgery within 4 weeks prior to the first dose of the experimental treatment. Placement of an artificial vascular graft is not considered a major surgery.
Previous/Current Concomitant Treatments
217. Participants must have previously received STEAP1 targeted therapy.
218. Participants must have experienced disease progression or intolerance to abiraterone treatment.
219. Participants must have previously received any chemotherapy regimen for mCRPC and/or received >6 cycles of docetaxel treatment for mHSPC.
220. Received any anticancer therapy, immunotherapy, or investigational drug within 4 weeks prior to the first dose of trial treatment, excluding androgen-suppressing therapies (e.g., luteinizing hormone-releasing hormone/gonadotropin-releasing hormone [LHRH/GnRH] analogs [agonists/antagonists]).
221. Received prostate-specific cell membrane antigen (PSMA) radioligand therapy (RLT) within 3 months of the first dose of trial treatment. Participants who received <2 cycles of PSMA RLT within 6 weeks of the first dose of trial treatment are also excluded.
222. Received radioactive seed therapy (radium-223) within 2 months of the first dose of trial treatment.
224. Received palliative radiation therapy within 2 weeks prior to the first dose of trial treatment. All radiation-related toxicities in the participant must have resolved.
225. Concurrently receiving cytotoxic chemotherapy, ARPI, immunotherapy, RLT, PARP inhibitors, biologics, or trial treatment.
Note: PARP inhibitor treatment can be received as long as more than 4 weeks have passed since the first dose of experimental treatment.
226. Received live virus and live attenuated vaccine treatment within 4 weeks prior to the first dose of experimental treatment.
Previously/currently participating in other clinical trials.
227. Currently receiving treatment with other experimental devices or drugs, or having completed treatment with other experimental devices or drugs less than 30 days ago. This does not apply to other experimental procedures or participation in observational studies.
Other exclusion criteria:
228. Participants who do not wish to avoid donating sperm during treatment, and participants whose partners are pregnant or of childbearing potential, who do not wish to abstain from sexual intercourse (avoiding heterosexual intercourse) or use contraception during treatment and for an additional 6 months after the last dose of xaluritamig, an additional 3 weeks after the last dose of abiraterone acetate, a 4-month period after the last dose of cabazitaxel, or a 4-month period after the last dose of docetaxel.
229 To the best of the participant's and the trial administrator's knowledge, the participant may be unable to complete all trial follow-ups or procedures as required by the trial plan, and/or cooperate with all required trial procedures (e.g., clinical outcome assessment).
230 Other clinically significant abnormalities, conditions, medical histories, or evidence (other than those listed above) that, in the opinion of the trial administrator or Amgen physician (if consulted), may jeopardize the participant's safety or affect trial assessment, procedures, or completion.
The Estimated Number of Participants
-
Taiwan
60 participants
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Global
750 participants
