Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer
← catalyst calendarNCT04221542 · readout in 1,310 d
Sponsored by Amgen (industry) · AMGN — their whole pipeline →. With BeiGene, BeOne (China only).
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
479estimated
Sites
57
Countries
Australia, China, Germany +7
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-03-04 | actual | When the study began enrolling |
| Primary completion | 2030-03-22 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2032-03-21 | estimated | The whole study's end, after follow-up |
| First posted | 2020-01-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Prostate Cancer
Interventions
- Drug: AMG 509 — also filed as xaluritamig
- Drug: Abiraterone
- Drug: Enzalutamide
Primary outcomes
what the primary-completion date above is the date OFParts 1-5 and 7: Incidence of Treatment-emergent Adverse Events
measured 3 years
Parts 1-5 and 7: Incidence of Treatment-related Adverse Events
measured 3 years
Parts 1-5 and 7 Dose Exploration Cohorts Only: Dose Limiting Toxicities (DLTs)
measured 28 days
Parts 1-5 and 7: Number of Participants with Changes in Vital Signs
measured 3 years
Parts 1-5 and 7: Number of Participants with Changes in Electrocardiogram (ECG) Records
measured 3 years
Parts 1-5 and 7: Number of Participants with Changes in Clinical Laboratory Test Results
measured 3 years
Part 6: Objective Response (OR) per RECIST v1.1
measured 3 years
Publications
- PMID 37861461 — cited as background
- PMID 40765197 — cited as background
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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