Clinical Trials List
Protocol Number20180146
NCT Number(ClinicalTrials.gov Identfier)NCT04221542
2021-04-01 - 2025-10-31
Phase I
Recruiting2
ICD-10C61
Malignant neoplasm of prostate
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9185
Malignant neoplasm of prostate
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Amgen Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Yu-Chieh Tsai Division of Hematology & Oncology
- CHING-CHU LU Division of Nuclear Medicine
- Jih-Hsiang Lee Division of Hematology & Oncology
- Yeong-Shiau Pu Division of Urology
- 徐偉勛 Division of Hematology & Oncology
- - - Division of Urology
- FU-JEN HSUEH Division of Hematology & Oncology
- CHUNG-HSIN CHEN Division of Urology
- 吳宗哲 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Linkou Chang Gung Medical Foundation
Taiwan National PI
林永昌
Co-Principal Investigator
- 黃文冠 Division of Hematology & Oncology
- Kai-Jie Yu Division of Hematology & Oncology
- 黃亮鋼 Division of Hematology & Oncology
- 沈鼎文 Division of Radiology
- 張境夫 Division of Hematology & Oncology
- 林柏宏 Division of Hematology & Oncology
- I-hung Shao Division of Hematology & Oncology
- PO-HUNG LIN Division of Hematology & Oncology
- Ming-Mo Hou Division of Hematology & Oncology
- Rita cheng Division of Hematology & Oncology
- Hong-Cheng Gan Division of Hematology & Oncology
- Jing-Ren Tseng Division of Nuclear Medicine
- Po-Jung Su Division of Hematology & Oncology
- See-Tong Pang Division of Hematology & Oncology
- Yuan-Cheng Chu Division of Hematology & Oncology
- Feng-Yuan Liu Division of Nuclear Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic Castration-Resistant Prostate Cancer
Objectives
Evaluate the safety and tolerability of AMG 509 in adult subjects and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
Test Drug
AMG 509
Active Ingredient
AMG 509
Dosage Form
Vial
Dosage
10
Endpoints
Primary Outcome Measures :
Incidence of treatment-emergent adverse events [ Time Frame: 3 years ]
Incidence of treatment-related adverse events [ Time Frame: 3 years ]
Dose limiting toxicities (DLTs) [ Time Frame: 3 years ]
Number of participants with changes in vital signs [ Time Frame: 3 years ]
Number of participants with changes in the electrocardiogram (ECG) records [ Time Frame: 3 years ]
Number of participants with changes in the clinical laboratory tests results [ Time Frame: 3 years ]
Secondary Outcome Measures :
Maximum serum concentration (Cmax) for AMG 509 [ Time Frame: 3 years ]
To characterize the pharmacokinetics (PK) of AMG 509
Time to maximum serum concentration (Tmax) for AMG 509 [ Time Frame: 3 years ]
To characterize the pharmacokinetics (PK) of AMG 509
Minimum serum concentration (Cmin) for AMG 509 [ Time Frame: 3 years ]
To characterize the pharmacokinetics (PK) of AMG 509
Area under the concentration-time curve (AUC) over the dosing interval for AMG 509 [ Time Frame: 3 years ]
To characterize the pharmacokinetics (PK) of AMG 509
Accumulation following multiple dosing for AMG 509 [ Time Frame: 3 years ]
To characterize the pharmacokinetics (PK) of AMG 509
Objective response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509
Prostate specific antigen (PSA) response [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509
Duration of response (DOR) (radiographic and PSA) [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509
Time to progression (radiographic and PSA) [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509
Progression-free survival (PFS) (radiographic and PSA) [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509
1, 2, and 3-year overall survival (OS) [ Time Frame: Year 1, 2, and 3 ]
To evaluate preliminary anti-tumor activity of AMG 509
Circulating tumor cells response (CTC0) [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509
Rate of circulating tumor cells CTC conversion [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509
Time to symptomatic skeletal events [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Alkaline phosphatase (total, bone) [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Lactate dehydrogenase (LDH) [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Hemoglobin [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Urine N-telopeptide [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Neutrophil-to-lymphocyte ratio [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Incidence of treatment-emergent adverse events [ Time Frame: 3 years ]
Incidence of treatment-related adverse events [ Time Frame: 3 years ]
Dose limiting toxicities (DLTs) [ Time Frame: 3 years ]
Number of participants with changes in vital signs [ Time Frame: 3 years ]
Number of participants with changes in the electrocardiogram (ECG) records [ Time Frame: 3 years ]
Number of participants with changes in the clinical laboratory tests results [ Time Frame: 3 years ]
Secondary Outcome Measures :
Maximum serum concentration (Cmax) for AMG 509 [ Time Frame: 3 years ]
To characterize the pharmacokinetics (PK) of AMG 509
Time to maximum serum concentration (Tmax) for AMG 509 [ Time Frame: 3 years ]
To characterize the pharmacokinetics (PK) of AMG 509
Minimum serum concentration (Cmin) for AMG 509 [ Time Frame: 3 years ]
To characterize the pharmacokinetics (PK) of AMG 509
Area under the concentration-time curve (AUC) over the dosing interval for AMG 509 [ Time Frame: 3 years ]
To characterize the pharmacokinetics (PK) of AMG 509
Accumulation following multiple dosing for AMG 509 [ Time Frame: 3 years ]
To characterize the pharmacokinetics (PK) of AMG 509
Objective response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509
Prostate specific antigen (PSA) response [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509
Duration of response (DOR) (radiographic and PSA) [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509
Time to progression (radiographic and PSA) [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509
Progression-free survival (PFS) (radiographic and PSA) [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509
1, 2, and 3-year overall survival (OS) [ Time Frame: Year 1, 2, and 3 ]
To evaluate preliminary anti-tumor activity of AMG 509
Circulating tumor cells response (CTC0) [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509
Rate of circulating tumor cells CTC conversion [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509
Time to symptomatic skeletal events [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Alkaline phosphatase (total, bone) [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Lactate dehydrogenase (LDH) [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Hemoglobin [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Urine N-telopeptide [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Neutrophil-to-lymphocyte ratio [ Time Frame: 3 years ]
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Inclution Criteria
Inclusion Criteria:
Parts 1, 2, and 5: prior taxane exposure Participants with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (eg, abiraterone acetate and/or enzalutamide, apalutamide, darolutamide, bicalutamide, or equivalent) and have failed at least 1 (but not more than 2) taxane regimens including for mHSPC (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Note: A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane.
Dose exploration phase: Novel antiandrogen therapy must have been given for treatment of metastatic disease.
Dose expansion phase: participants must not have had more than 2 NHTs and 2 taxane regimens in any setting, and an additional up to 2 other systemic anti-cancer treatments are allowed (eg, anti-PD1, PARP inhibitors, radioligand therapies, sipuleucel-T, experimental agents) Note: Combinations are considered one systemic anti-cancer treatment.
Parts 4A and 4B: prior taxane exposure
Participants with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide, bicalutamide or equivalent) given for hormone-sensitive prostate cancer (HSPC) or non-metastatic CRPC and have failed up to 1 taxane regimen which must have been given for HSPC only (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen).
4A: Participants planning to receive abiraterone acetate for the first time (participants who received prior abiraterone acetate are not eligible).
4B: Participants planning to receive enzalutamide for the first time (participants who received prior enzalutamide/apalutamide or daralutamide are not eligible).
Parts 3 and 4C: no prior taxane exposure
a. Participants with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide, bicalutamide or equivalent) given in any disease setting and who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen.
Participants must have undergone bilateral orchiectomy or be on continuous androgen-deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist or antagonist.
Total serum testosterone <= 50 ng/dL or 1.7 nmol/L.
Evidence of progressive disease, defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria:
PSA level >= 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart.
nodal or visceral progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with PCGW3 modifications.
appearance of 2 or more new lesions in bone scan.
Eastern Cooperative Oncology Group performance status of 0-1.
Adequate organ function, defined as follows:
Hematological function:
absolute neutrophil count >= 1 x 10^9/L (without growth factor support within 7 days from screening assessment).
platelet count >= 75 x 10^9/L (without platelet transfusion within 7 days from screening assessment).
hemoglobin >= 9 g/dL (90 g/L) (without blood transfusion within 7 days from screening assessment).
Renal function:
1. estimated glomerular filtration rate based on Modification of Diet in Renal Disease calculation >= 30 ml/min/1.73 m^2.
Hepatic function:
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN) (or < 5 x ULN for participants with liver involvement).
total bilirubin (TBL) < 1.5 x ULN (or < 2 x ULN for participants with liver metastases).
Cardiac function:
left ventricular ejection fraction > 50% (2-D transthoracic echocardiogram [ECHO] is the preferred method of evaluation; multi-gated acquisition scan is acceptable if ECHO is not available).
Baseline electrocardiogram (ECG) QTcF <= 470 msec.
Parts 1, 2, and 5: prior taxane exposure Participants with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (eg, abiraterone acetate and/or enzalutamide, apalutamide, darolutamide, bicalutamide, or equivalent) and have failed at least 1 (but not more than 2) taxane regimens including for mHSPC (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Note: A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane.
Dose exploration phase: Novel antiandrogen therapy must have been given for treatment of metastatic disease.
Dose expansion phase: participants must not have had more than 2 NHTs and 2 taxane regimens in any setting, and an additional up to 2 other systemic anti-cancer treatments are allowed (eg, anti-PD1, PARP inhibitors, radioligand therapies, sipuleucel-T, experimental agents) Note: Combinations are considered one systemic anti-cancer treatment.
Parts 4A and 4B: prior taxane exposure
Participants with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide, bicalutamide or equivalent) given for hormone-sensitive prostate cancer (HSPC) or non-metastatic CRPC and have failed up to 1 taxane regimen which must have been given for HSPC only (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen).
4A: Participants planning to receive abiraterone acetate for the first time (participants who received prior abiraterone acetate are not eligible).
4B: Participants planning to receive enzalutamide for the first time (participants who received prior enzalutamide/apalutamide or daralutamide are not eligible).
Parts 3 and 4C: no prior taxane exposure
a. Participants with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide, bicalutamide or equivalent) given in any disease setting and who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen.
Participants must have undergone bilateral orchiectomy or be on continuous androgen-deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist or antagonist.
Total serum testosterone <= 50 ng/dL or 1.7 nmol/L.
Evidence of progressive disease, defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria:
PSA level >= 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart.
nodal or visceral progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with PCGW3 modifications.
appearance of 2 or more new lesions in bone scan.
Eastern Cooperative Oncology Group performance status of 0-1.
Adequate organ function, defined as follows:
Hematological function:
absolute neutrophil count >= 1 x 10^9/L (without growth factor support within 7 days from screening assessment).
platelet count >= 75 x 10^9/L (without platelet transfusion within 7 days from screening assessment).
hemoglobin >= 9 g/dL (90 g/L) (without blood transfusion within 7 days from screening assessment).
Renal function:
1. estimated glomerular filtration rate based on Modification of Diet in Renal Disease calculation >= 30 ml/min/1.73 m^2.
Hepatic function:
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN) (or < 5 x ULN for participants with liver involvement).
total bilirubin (TBL) < 1.5 x ULN (or < 2 x ULN for participants with liver metastases).
Cardiac function:
left ventricular ejection fraction > 50% (2-D transthoracic echocardiogram [ECHO] is the preferred method of evaluation; multi-gated acquisition scan is acceptable if ECHO is not available).
Baseline electrocardiogram (ECG) QTcF <= 470 msec.
Exclusion Criteria
Exclusion Criteria:
Pathological finding consistent with pure small cell, neuroendocrine carcinoma of the prostate or any other histology different from adenocarcinoma.
Radiation therapy within 4 weeks of first dose (or local or focal radiotherapy within 2 weeks of first dose).
Untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with a history of treated CNS metastases are eligible if there is radiographic evidence of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.
Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis); for arterial thrombosis within 12 months of AMG 509 initiation; for venous thrombosis, 6 months and stable on anti-coagulation.
Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 509 with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement and confirmed by a cardiologist more than 6 months prior to first dose of AMG 509.
Any anti-cancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone (LHRH)/GnRH analogue (agonist/antagonist). Participants on a stable bisphosphonate or denosumab regimen for >= 30 days prior to enrollment are eligible.
Pathological finding consistent with pure small cell, neuroendocrine carcinoma of the prostate or any other histology different from adenocarcinoma.
Radiation therapy within 4 weeks of first dose (or local or focal radiotherapy within 2 weeks of first dose).
Untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with a history of treated CNS metastases are eligible if there is radiographic evidence of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.
Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis); for arterial thrombosis within 12 months of AMG 509 initiation; for venous thrombosis, 6 months and stable on anti-coagulation.
Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 509 with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement and confirmed by a cardiologist more than 6 months prior to first dose of AMG 509.
Any anti-cancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone (LHRH)/GnRH analogue (agonist/antagonist). Participants on a stable bisphosphonate or denosumab regimen for >= 30 days prior to enrollment are eligible.
The Estimated Number of Participants
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Taiwan
25 participants
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Global
577 participants
