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Clinical trial · no report yet · Phase 1
NCT04221542 trial: what clinicians have said so far
Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer
- NCT04221542 ↗
- Recruiting
- Amgen
- Focused size, estimated: 1–150 verified statements
We haven't built an HCP commentary report on NCT04221542 (xaluritamig (AMG 509); xaluritamig (AMG 509) plus abiraterone; xaluritamig (AMG 509) plus enzalutamide in metastatic castration-resistant prostate cancer) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on NCT04221542 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Indexed so far | |
|---|---|
| 3 posts on X |
The trial
ClinicalTrials.gov- Official title
- A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer
- Phase
- Phase 1
- Status
- Recruiting
- Conditions
- Prostate Cancer
- Interventions
- AMG 509; Abiraterone; Enzalutamide
- Arms
- Part 1: AMG 509 Intravenous (IV) Monotherapy · Experimental
- Part 2: AMG 509 Subcutaneous (SC) Monotherapy · Experimental
- Part 3: AMG 509 IV Monotherapy in Earlier Lines of Treatment · Experimental
- Part 4: AMG 509 IV Combination Therapy · Experimental
- Part 5: AMG 509 IV Monotherapy in Outpatient Setting · Experimental
- Part 6: AMG 509 IV as Monotherapy and Combination Therapy With Abiraterone Acetate · Experimental
- Part 7 (China only): AMG 509 IV as Monotherapy or in Combination With Abiraterone Acetate · Experimental
- Enrollment
- 479 (estimated)
- Primary outcomes
- Parts 1-5 and 7: Incidence of Treatment-emergent Adverse Events
- Parts 1-5 and 7: Incidence of Treatment-related Adverse Events
- Parts 1-5 and 7 Dose Exploration Cohorts Only: Dose Limiting Toxicities (DLTs)
- Parts 1-5 and 7: Number of Participants with Changes in Vital Signs
- Parts 1-5 and 7: Number of Participants with Changes in Electrocardiogram (ECG) Records
- Parts 1-5 and 7: Number of Participants with Changes in Clinical Laboratory Test Results
- Part 6: Objective Response (OR) per RECIST v1.1
- Sponsor
- Amgen with BeiGene, BeOne (China only)
- Start
- Mar 4, 2020
- Primary completion
- Mar 22, 2030 (estimated)
- Results posted
- No
- Registry record
- NCT04221542 · updated Aug 21, 2026
Publications
linked from the registry- Kelly WK, Danila DC, Lin CC, Lee JL, Matsubara N, Ward PJ, Armstrong AJ, Pook D, Kim M, Dorff TB, Fischer S, Lin YC, Horvath LG, Sumey C, Yang Z, Jurida G, Smith KM, Connarn JN, Penny HL, Stieglmaier J, Appleman LJ. Xaluritamig, a STEAP1 x CD3 XmAb 2+1 Immune Therapy for Metastatic Castration-Resistant Prostate Cancer: Results from Dose Exploration in a First-in-Human Study. Cancer Discov. 2024 Jan 12;14(1):76-89. doi: 10.1158/2159-8290.CD-23-0964. PubMed 37861461
- Kuipers-Connarn JN, Pourzanjani A, Bose M, Modi S, Stieglmaier J, Murphy A, Mehta K, Upreti VV. Clinical Pharmacology Characterization and Dose Selection of Xaluritamig, a Next Generation XmAb(R) 2+1 T-Cell Engager, in Prostate Cancer Patients. J Clin Pharmacol. 2025 Dec;65(12):1676-1686. doi: 10.1002/jcph.70074. Epub 2025 Aug 5. PubMed 40765197