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Bi-specific T-cell Engager

Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC

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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

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 more

Secondary 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 more

Awards & 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