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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
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Metastatic Castration Resistant Prostate Cancer
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~4720
Cytochrome P450 (CYP) Cocktail
2019
Completed Phase 1
~220
acapatamab
2019
Completed Phase 1
~220
Pembrolizumab
2017
Completed Phase 3
~2810
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Who is running the clinical trial?
AmgenLead Sponsor
1,427 Previous Clinical Trials
1,384,474 Total Patients Enrolled
14 Trials studying Prostate Cancer
4,702 Patients Enrolled for Prostate Cancer
MDStudy DirectorAmgen
967 Previous Clinical Trials
928,802 Total Patients Enrolled
9 Trials studying Prostate Cancer
4,607 Patients Enrolled for Prostate Cancer
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