Trials / Terminated
TerminatedNCT04631601
Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Master Protocol Evaluating the Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Male
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This is a master protocol designed to evaluate the safety and efficacy of investigational therapies in participants with metastatic castration-resistant prostate cancer (mCRPC).
Detailed description
This is a master protocol designed to evaluate the safety, tolerability, and maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) and efficacy of Acapatamab, in combination with enzalutamide, abiraterone, or the PD1 inhibitor AMG 404, AMG 404 monotherapy, as well as Acapatamab monotherapy, in participants with metastatic castration-resistant prostate cancer (mCRPC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acapatamab | Acapatamab will be administered as an intravenous (IV) infusion. |
| DRUG | Enzalutamide | Enzalutamide will be administered orally. |
| DRUG | Abiraterone | Abiraterone will be administered orally. |
| DRUG | AMG 404 | AMG 404 will be administered as an intravenous (IV) infusion. |
Timeline
- Start date
- 2021-01-15
- Primary completion
- 2023-10-23
- Completion
- 2023-10-23
- First posted
- 2020-11-17
- Last updated
- 2025-10-07
Locations
14 sites across 6 countries: United States, Australia, Denmark, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04631601. Inclusion in this directory is not an endorsement.