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Hormone Therapy

Acapatamab for Prostate Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial will test new treatments for men with mCRPC. The goal is to find out if they are safe and effective.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose exploration only: Number of participants who experience dose limiting toxicities (DLTs)
Number of participants who experience a clinically significant change in clinical laboratory tests
Number of participants who experience a clinically significant change in vital signs
+2 more
Secondary outcome measures
Accumulation ratio based on area under the concentration-time curve (AUC)
Area under the concentration-time curve (AUC)
Change from baseline in prostate-specific membrane antigen (PSMA)-negative disease burden assessed using 18F-fluorodeoxyglucose (F-FDG) positron emission tomography/computed tomography (PET/CT)
+18 more

Trial Design

11Treatment groups
Experimental Treatment
Active Control
Group I: Acapatamab and Enzalutamide: Dose ExplorationExperimental Treatment2 Interventions
The dose-exploration part of the study will estimate the MTD/recommended phase 2 dose (RP2D) of Acapatamab in combination with enzalutamide.
Group II: Acapatamab and Enzalutamide: Dose Expansion Asia CohortExperimental Treatment2 Interventions
Following dose exploration, dose expansion will be conducted in the Asia cohort at the combination MTD/RP2D determined in dose exploration to confirm the safety, tolerability and PK of Acapatamab in combination with enzalutamide for subjects in Asia.
Group III: Acapatamab and Enzalutamide: Dose ExpansionExperimental Treatment2 Interventions
Following dose exploration, dose expansion will be conducted to confirm the safety and tolerability of the selected dose and to further evaluate the efficacy of Acapatamab in combination with enzalutamide.
Group IV: Acapatamab and Abiraterone: Dose ExplorationExperimental Treatment2 Interventions
The dose exploration part of the study will estimate the MTD/recommended phase 2 dose (RP2D) of Acapatamab in combination with abiraterone.
Group V: Acapatamab and Abiraterone: Dose Expansion Asia CohortExperimental Treatment2 Interventions
Following dose exploration, dose expansion will be conducted in the Asia cohort at the combination MTD/RP2D determined in dose exploration to confirm the safety, tolerability and PK of Acapatamab in combination with abiraterone for subjects in Asia.
Group VI: Acapatamab and Abiraterone: Dose ExpansionExperimental Treatment2 Interventions
Following dose exploration, dose expansion will be conducted to confirm the safety and tolerability of the selected dose and to further evaluate the efficacy of Acapatamab in combination with abiraterone.
Group VII: Acapatamab and AMG 404: Dose ExplorationExperimental Treatment2 Interventions
The dose-exploration part of the study will estimate the MTD/RP2D of Acapatamab in combination with AMG 404.
Group VIII: Acapatamab and AMG 404: Dose Expansion Asia CohortExperimental Treatment2 Interventions
Following dose exploration, dose expansion will be conducted in the Asia cohort at the combination MTD/RP2D determined in dose exploration to confirm the safety, tolerability and PK of Acapatamab in combination with AMG 404 for subjects in Asia.
Group IX: Acapatamab and AMG 404: Dose ExpansionExperimental Treatment2 Interventions
Following dose exploration, dose expansion will be conducted to confirm the safety and tolerability of the selected dose and to further evaluate the efficacy of Acapatamab in combination with AMG 404.
Group X: Acapatamab MonotherapyExperimental Treatment1 Intervention
Acapatamab monotherapy is being conducted to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and efficacy of Acapatamab in subjects with mCRPC.
Group XI: AMG 404 MonotherapyActive Control1 Intervention
AMG 404 monotherapy is being conducted to evaluate the preliminary anti-tumor activity of PD-1 inhibition in the mCRPC population.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760
Abiraterone
2012
Completed Phase 4
~2830
AMG 404
2020
Completed Phase 1
~230

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,380 Previous Clinical Trials
1,379,556 Total Patients Enrolled
13 Trials studying Prostate Cancer
4,844 Patients Enrolled for Prostate Cancer
MDStudy DirectorAmgen
925 Previous Clinical Trials
926,579 Total Patients Enrolled
8 Trials studying Prostate Cancer
4,749 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04631601 — Phase 1 & 2
Prostate Cancer Research Study Groups: Acapatamab and Abiraterone: Dose Expansion, Acapatamab and Enzalutamide: Dose Exploration, AMG 404 Monotherapy, Acapatamab and AMG 404: Dose Expansion Asia Cohort, Acapatamab and Enzalutamide: Dose Expansion, Acapatamab and AMG 404: Dose Exploration, Acapatamab and Abiraterone: Dose Expansion Asia Cohort, Acapatamab and AMG 404: Dose Expansion, Acapatamab and Abiraterone: Dose Exploration, Acapatamab and Enzalutamide: Dose Expansion Asia Cohort, Acapatamab Monotherapy
Prostate Cancer Clinical Trial 2023: Abiraterone Highlights & Side Effects. Trial Name: NCT04631601 — Phase 1 & 2
Abiraterone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04631601 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility criteria of this experiment limited to individuals under 35 years old?

"This medical trial is enrolling patients who are of legal age and below 99 years old."

Answered by AI

What is the intended outcome of this research endeavor?

"The core focus of this study, estimated to take Up to 3 years, is the count of participants who endure dose limiting toxicities (DLTs). Additionally, researchers will analyze Neutrophil-to-lymphocyte ratio over Parts 1, 2 and 3; likewise they shall measure Concentration of hemoglobin and Time to progression during those same periods."

Answered by AI

Are there multiple locations in the United States facilitating this clinical trial?

"This clinical trial is being carried out at Norton Cancer Institute in Louisville, Kentucky, University of Chicago in Chicago, Illinois, and University of California at Irvine Medical Center in Orange, California as well as an additional 7 medical centres."

Answered by AI

To whom is this research opportunity available?

"This trial is currently seeking 136 individuals aged 18 to 99 with existing castration. Other eligibility requirements include being of legal age within the participant's country."

Answered by AI

How many participants are presently enrolled in this research endeavor?

"Unfortunately, for this particular trial, recruitment is currently suspended. The study was first posted on the 15th of January 2021 and last updated in June 2022. On the other hand, if you are seeking alternatives there are 1258 studies recruiting patients with castration and 171 trials looking for individuals to participate in Acapatamab research."

Answered by AI

Are there any past investigations involving Acapatamab?

"Currently, 171 Acapatamab medical trials are in progress with 45 of them being conducted at the Phase 3 level. The majority of these studies can be found in Leicester, Pennsylvania and beyond this there are another 10,082 locations running clinical research for this particular treatment."

Answered by AI

Is the current research study seeking additional participants?

"This clinical trial, which was posted on January 15th 2021 and last updated June 20th 2022 is no longer welcoming new participants. Nonetheless, 1429 other experimental studies are currently recruiting patients."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
University of Chicago
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)
2021. "Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04631601.
~15 spots leftby May 2025
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