Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new drug called acapatamab, which helps the immune system target and kill advanced prostate cancer cells that don't respond to hormone treatments.
Will I have to stop taking my current medications?
The trial requires that you stop any anticancer therapy or immunotherapy at least 4 weeks before starting the study, except for certain hormone therapies. If you are on chronic systemic corticosteroid therapy, you need to stop it 7 days before the first dose.
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose-exploration
Acapatamab is administered intravenously to estimate the maximum tolerated dose (MTD) and identify the recommended phase 2 dose (RP2D) based on emerging safety, efficacy, and pharmacodynamic data.
Treatment
Participants receive acapatamab alone or in combination with pembrolizumab, etanercept prophylaxis, or CYP phenotyping cocktail, with monitoring for safety and efficacy.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of prostate-specific antigen (PSA) response and progression-free survival.
What Are the Treatments Tested in This Trial?
Interventions
- Acapatamab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London