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Bi-specific T-cell Engager

acapatamab for Prostate Cancer

Phase 1
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 is testing a new drug for prostate cancer that has spread and is no longer responding to hormone therapy. The goal is to find the maximum tolerated dose and to see if the drug is effective.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer
  • 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
Number of participants with clinically significant changes in clinical laboratory tests
Number of participants with clinically significant changes in electrocardiogram (ECG)
Number of participants with clinically significant changes in vital signs
+3 more
Secondary outcome measures
1, 2 and 3-year overall survival (OS)
Accumulation ratio of acapatamab
Area under the concentration-time curve (AUC) over the dosing interval of acapatamab
+20 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Part 6: acapatamab + Cytochrome P450 (CYP) Cocktail Drug InteractionExperimental Treatment2 Interventions
Part 6: acapatamab is administered intravenously at RP2D/MTD. A CYP phenotyping cocktail will be administered orally.
Group II: Part 5: acapatamab Outpatient CohortExperimental Treatment1 Intervention
Part 5: acapatamab is administered intravenously at RP2D/MTD in an outpatient setting with 8-hour monitoring.
Group III: Part 4: acapatamab 24 Hour MonitoringExperimental Treatment1 Intervention
Part 4: acapatamab is administered intravenously at RP2D/MTD with 24-hour monitoring.
Group IV: Part 3: acapatamab + Etanercept ProphylaxisExperimental Treatment2 Interventions
Part 3: acapatamab is administered intravenously at RP2D/MTD levels. Etanercept will be administered subcutaneously in cycle 1 only.
Group V: Part 2: acapatamab + PembrolizumabExperimental Treatment2 Interventions
Part 2: acapatamab is administered intravenously at the MTD/RP2D. Pembrolizumab will be administered intravenously.
Group VI: Part 1 Dose-exploration: acapatamab treatmentExperimental Treatment1 Intervention
Part 1 dose-exploration: acapatamab is administered intravenously. The dose-exploration phase of the study will estimate the MTD of acapatamab. RP2D may be identified based on emerging safety, efficacy, and pharmacodynamic data prior to reaching an MTD.
Group VII: Part 1 Dose-expansion: acapatamab treatmentExperimental Treatment1 Intervention
Part 1 dose-expansion: acapatamab is administered intravenously at the MTD/RP2D.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etanercept
2005
Completed Phase 4
~4740
Cytochrome P450 (CYP) Cocktail
2019
Completed Phase 1
~220
acapatamab
2019
Completed Phase 1
~220
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,476 Total Patients Enrolled
12 Trials studying Prostate Cancer
4,632 Patients Enrolled for Prostate Cancer
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,919 Total Patients Enrolled
7 Trials studying Prostate Cancer
4,537 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

In what scenarios is acapatamab regularly utilized?

"Acapatamab is often utilized to treat unresectable melanoma, and has been successfully used in cases of microsatellite instability high as well as for those with a heightened risk of recurrence."

Answered by AI

How many participants have been recruited for this experiment?

"At this juncture, this medical research is not actively seeking out new patients. The trial was uploaded to clinicaltrials.gov on February 5th 2019 and the last update occurred on July 26th 2022. If you are searching for other studies related to prostate cancer, there are currently 1327 trials recruiting participants; additionally, 994 trials require volunteers with acapatamab-related conditions."

Answered by AI

Is this experiment being administered in numerous Canadian locations?

"Applicants to this trail will have the option to choose from 15 sites, some of which are located in Vancouver, Dallas and Long Beach. To reduce any transportation costs, it is recommended that individuals opt for the closest site possible."

Answered by AI

What are the chief aims of this investigation?

"The chief aim of this multi-year research endeavour is to determine the amount of participants with major alterations in electrocardiogram (ECG). Secondary objectives include understanding changes in pharmacokinetics - minimum serum concentration (Cmin), analysing PCWG3-recommended endpoints such as hemoglobin levels, and assessing other PCWG3-recommended endpoints including alkaline phosphatase [total, bone] across Parts 1 to 6."

Answered by AI

Is enrollment for this clinical trial still accessible?

"This research has concluded its recruitment phase. The trial was initially posted on February 5th 2019 and last edited July 26th 2022. For those seeking other opportunities, 1327 trials are presently recruiting patients with prostate cancer while 994 studies require participants for acapatamab related experiments."

Answered by AI

Are there any other investigations that have explored acapatamab's potential for treatment?

"Presently, 994 investigations for acapatamab are occurring with 132 in their final testing stage. Most of these trials have been established in Scottsdale, Arizona yet there is an additional 36362 sites where research on this drug can be conducted."

Answered by AI

Has the acapatamab drug been accepted by the Food and Drug Administration?

"Acapatamab has been classified with a score of 1, since this is an initial clinical trial and there are limited data to suggest efficacy or safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC
2019. "Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03792841.
~34 spots leftby Apr 2025
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