Trials / Terminated
TerminatedNCT03792841
Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Prostate Specific Membrane Antigen Half-life Extended Bispecific T-cell Engager Acapatamab in Subjects With Metastatic Castration-resistant Prostate Cancer
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 212 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A phase 1 study evaluating the safety, tolerability, pharmacokinetics, and efficacy of prostate specific membrane antigen half-life extended bispecific T-cell engager acapatamab in subjects with metastatic castration-resistant prostate cancer, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
Detailed description
This is a phase I, first-in-human study to evaluate the safety and tolerability of acapatamab; a half-life extended (HLE) bispecific T-cell engager (BiTE®) construct, alone and in combination with pembrolizumab, etanercept prophylaxis and cytochrome P450 (CYP) phenotyping cocktail in subjects with metastatic castration-resistant prostate cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | acapatamab | Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer |
| DRUG | Pembrolizumab | Combined with acapatamab for investigational treatment of mCRPC |
| DRUG | Etanercept | Prophylaxis for acapatamab-related cytokine release syndrome. |
| DRUG | Cytochrome P450 (CYP) Cocktail | Evaluate the effect of co-administration of multiple dosing of acapatamab on plasma |
Timeline
- Start date
- 2019-02-05
- Primary completion
- 2023-06-29
- Completion
- 2023-06-29
- First posted
- 2019-01-03
- Last updated
- 2025-10-16
Locations
30 sites across 10 countries: United States, Australia, Austria, Belgium, Canada, France, Japan, Netherlands, Singapore, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03792841. Inclusion in this directory is not an endorsement.