The overall aim of the trial is to evaluate the safety, tolerability, and pharmacokinetics (PK) of AMG 509 (monotherapy and in combination with abiraterone acetate and enzalutamide) and to evaluate preliminary efficacy. As of Protocol Amendment 10 (09 July 2025), only Parts 4A expansion, 6, and 7 are open to accrual.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
479
AMG 509 administered as an IV infusion (Parts 1, 3, 4 and 5) or SC injection (Part 2).
Abiraterone administered as oral tablets.
Enzalutamide administered as oral tablets.
Parts 1-5 and 7: Incidence of Treatment-emergent Adverse Events
Time frame: 3 years
Parts 1-5 and 7: Incidence of Treatment-related Adverse Events
Time frame: 3 years
Parts 1-5 and 7 Dose Exploration Cohorts Only: Dose Limiting Toxicities (DLTs)
Time frame: 28 days
Parts 1-5 and 7: Number of Participants with Changes in Vital Signs
Time frame: 3 years
Parts 1-5 and 7: Number of Participants with Changes in Electrocardiogram (ECG) Records
Time frame: 3 years
Parts 1-5 and 7: Number of Participants with Changes in Clinical Laboratory Test Results
Time frame: 3 years
Part 6: Objective Response (OR) per RECIST v1.1
Time frame: 3 years
Parts 1-7: Maximum Serum Concentration (Cmax) for AMG 509
To characterize the pharmacokinetics (PK) of AMG 509
Time frame: 3 years
Parts 1-7: Time to Maximum Serum Concentration (Tmax) for AMG 509
To characterize the pharmacokinetics (PK) of AMG 509
Time frame: 3 years
Parts 1-7: Minimum Serum Concentration (Cmin) for AMG 509
To characterize the pharmacokinetics (PK) of AMG 509
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City of Hope National Medical Center
Duarte, California, United States
RECRUITINGProvidence Saint Jude Medical Center
Fullerton, California, United States
RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGRocky Mountain Cancer Centers
Aurora, Colorado, United States
RECRUITINGYale New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGIndiana University
Indianapolis, Indiana, United States
RECRUITINGMidAmerica Cancer Care
Merriam, Kansas, United States
RECRUITINGTulane Medical Center
New Orleans, Louisiana, United States
COMPLETEDWashington University
St Louis, Missouri, United States
RECRUITING...and 47 more locations
Time frame: 3 years
Parts 1-7: Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for AMG 509
To characterize the pharmacokinetics (PK) of AMG 509
Time frame: 3 years
Parts 1-7: Accumulation Following Multiple Dosing for AMG 509
To characterize the pharmacokinetics (PK) of AMG 509
Time frame: 3 years
Parts 1-5 and 7: OR per RECIST v1.1
To evaluate preliminary anti-tumor activity of AMG 509
Time frame: 3 years
Parts 1-7: Prostate Specific Antigen (PSA) Response
To evaluate preliminary anti-tumor activity of AMG 509
Time frame: 3 years
Parts 1-5 and 7: PSA Decline of at Least 50% From Baseline at 12 Weeks
To evaluate preliminary anti-tumor activity of AMG 509
Time frame: Week 12
Parts 1-7: Radiographic Duration of Response (DOR)
To evaluate preliminary anti-tumor activity of AMG 509
Time frame: 3 years
Parts 1-5 and 7: PSA DOR
To evaluate preliminary anti-tumor activity of AMG 509
Time frame: 3 years
Parts 1-5 and 7: Radiographic Time to Progression
To evaluate preliminary anti-tumor activity of AMG 509
Time frame: 3 years
Parts 1-5 and 7: PSA Time to Progression
To evaluate preliminary anti-tumor activity of AMG 509
Time frame: 3 years
Parts 1-5 and 7: Radiographic Progression-free Survival (PFS)
To evaluate preliminary anti-tumor activity of AMG 509
Time frame: 3 years
Parts 1-5 and 7: PSA PFS
To evaluate preliminary anti-tumor activity of AMG 509
Time frame: 3 years
Part 6: Radiographic PFS per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1
To evaluate preliminary anti-tumor activity of AMG 509
Time frame: 3 years
Parts 1-2, 5 and 7: 6 Month Radiographic PFS
To evaluate preliminary anti-tumor activity of AMG 509
Time frame: 6 months
Part 3 and 4: 1, 2, and 3-year Radiographic PFS
To evaluate preliminary anti-tumor activity of AMG 509
Time frame: Year 1, 2, and 3
Parts 1-5: 1, 2, and 3-year Overall Survival (OS)
To evaluate preliminary anti-tumor activity of AMG 509
Time frame: Year 1, 2, and 3
Parts 1-5: Circulating Tumor Cells Response (CTC0)
To evaluate preliminary anti-tumor activity of AMG 509
Time frame: 3 years
Parts 1-5: Rate of Circulating Tumor Cells (CTC) Conversion
To evaluate preliminary anti-tumor activity of AMG 509
Time frame: 3 years
Parts 1-5: Time to Symptomatic Skeletal Events
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Time frame: 3 years
Parts 1-5: Alkaline Phosphatase (Total, Bone)
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Time frame: 3 years
Parts 1-5: Lactate Dehydrogenase (LDH)
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Time frame: 3 years
Parts 1-5: Hemoglobin
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Time frame: 3 years
Parts 1-5: Urine N-telopeptide
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Time frame: 3 years
Parts 1-5: Neutrophil-to-lymphocyte Ratio
To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Time frame: 3 years
Part 6: Incidence of Treatment-emergent Adverse Events
Time frame: 3 years
Part 6: Incidence of Treatment-related Adverse Events
Time frame: 3 years
Part 6: Number of Participants with Changes in Vital Signs
Time frame: 3 years
Part 6: Number of Participants with Changes in Clinical Laboratory Test Results
Time frame: 3 years
Part 6: Disease Control per RECIST v1.1
Time frame: 3 years
Parts 6 and 7: OS
Time frame: 3 years