Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)

Stopped early · Phase 1/Phase 2

Conditions studied: Metastatic Castration-resistant Prostate Cancer

In brief

This is a master protocol designed to evaluate the safety and efficacy of investigational therapies in participants with metastatic castration-resistant prostate cancer (mCRPC).

Key facts

Study ID

NCT04631601

Run by

Amgen

People needed

65

Starts

2021-01-15

Expected to finish

2023-10-23

Last updated by the study team

2025-10-07

Who can join

Age: 18 and older, up to 99. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age (or legal adult age within country)
• Subject has provided informed consent prior to initiation of any study-specific activities/procedures
• Subjects with mCRPC with histologically or cytologically confirmed adenocarcinoma of the prostate
• Subjects should have undergone bilateral orchiectomy or should be on continuous androgen deprivation therapy with a gonadotropin releasing hormone agonist or antagonist (testosterone ≤ 50 ng/dL (or 1.7 nmol/L))

You may not qualify if…

• Central nervous system (CNS) metastases or leptomeningeal disease
• History or presence of clinically relevant CNS pathology
• Confirmed history or current autoimmune disease or other diseases requiring permanent immunosuppressive therapy
• Myocardial infarction, uncontrolled hypertension, unstable angina, cardiac arrhythmia requiring medication, and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months
• Prior treatment with a taxane for mCRPC
• Major surgery and/or Radiation within 4 weeks
• History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection unless agreed upon with medical monitor and meeting the following criteria:
• Negative test for SARS-CoV-2 RNA by real time polymerase chain reaction (RT-PCR) within 72 hours of first dose of Acapatamab (or AMG 404 in Part 3)
• No acute symptoms of COVID-19 disease within 10 days prior to first dose of Acapatamab (or AMG 404 in Part 3) (counted from day of positive test for asymptomatic subjects)
• Prior/Concurrent Clinical Study Experience
• Currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded with the exception of investigational scans.
• Subprotocol A only:
• Inclusion criteria
• Subjects planning to receive enzalutamide for the first time for mCRPC
• Exclusion criteria
• Use of strong CYP2C8 inhibitors or strong CYP3A4 inducers
• Use of narrow therapeutic index drugs that are substrates of CYP3A4, CYP2C9 or CYP2C19
• Subprotocol B only:
• Inclusion criteria
• Subjects planning to receive abiraterone for the first time for mCRPC Exclusion criteria
• Baseline moderate and severe hepatic impairment (Child-Pugh Class B and C)
• Presence of uncontrolled hypertension, hypokalemia, or fluid retention
• History or presence of adrenocortical insufficiency
• Use of concomitant medications that are sensitive substrates for CYP2D6 with a narrow therapeutic index
• Use of strong CYP3A4 inducers

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California at Irvine Medical Center — Orange, California, United States
• University of California San Francisco Mission Bay Campus — San Francisco, California, United States
• University of Chicago — Chicago, Illinois, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• St Vincents Hospital Sydney — Darlinghurst, New South Wales, Australia
• Rigshospitalet — København Ø, Denmark
• Clinica Universidad de Navarra — Pamplona, Navarre, Spain
• Skanes universitetssjukhus — Lund, Sweden
• Karolinska Universitetssjukhuset Solna — Stockholm, Sweden
• Akademiska sjukhuset — Uppsala, Sweden
• Royal Marsden Hospital — Sutton, United Kingdom

Full record on ClinicalTrials.gov

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