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Also known as JNJ-95298177
ARX517 · 1 trial · 1 indication
Incidence and severity of adverse events or serious adverse events of ARX517 alone or in combination with ARPIs will be assessed to determine the safety and tolerability of the treatment using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5 (CTCAE).
| Arm | Type | Description |
|---|---|---|
| ARX517 | EXPERIMENTAL | ARX517 will be administered via intravenous (IV) infusion, with the initial treatment regimen by weight-based infusion at an interval of every 3 weeks. Other treatment regimen may be explored. |
| ARX517+Apalutamide | EXPERIMENTAL | ARX517 and apalutamide |
| ARX517+AAP | EXPERIMENTAL | ARX517 and abiraterone acetate plus prednisone(AAP) |
| Name | Type | Description |
|---|---|---|
| ARX517 | DRUG | ARX517 is an ADC consisting of a humanized anti-PSMA monoclonal antibody (mAb) (IgG1κ) covalently conjugated to two (2) proprietary microtubule-disrupting toxins referred to as AS269. |
| Apalutamide | DRUG | Oral tablet and will be given once daily by mouth. |
| Abiraterone acetate | DRUG | Oral tablet and will be given once daily by mouth. |
| Prednisone | DRUG | Oral tablet and will be given once daily in metastatic castration-sensitive prostate cancer( mCSPC) and twice daily in metastatic castration-resistant prostate cancer (mCRPC) cohort by mouth. |
Key Inclusion Criteria: * Male and ≥18 years at the time of providing written informed consent. * Histologically confirmed prostate adenocarcinoma. * For subjects who have not undergone an orchiectomy, must be undergoing treatment with a luteinizing hormone-releasing hormone (LHRH) agonist or antag...
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ARX517 is an investigational therapy being studied for the treatment of metastatic prostate cancer. It is being developed as a monotherapy or in combination therapy for adult male patients with this condition. ARX517 has not been approved for any indication and remains in clinical development.
ARX517 is being developed by Johnson & Johnson, which trades under the ticker symbol JNJ. The company is the sponsor of the clinical program evaluating ARX517 in metastatic prostate cancer.
ARX517 is in Phase 1 clinical development. The single registered trial for ARX517 is a Phase 1 study, and it is currently active but not recruiting participants. ARX517 has not been approved by the FDA or any regulatory agency.
ARX517 is being evaluated in one clinical trial, NCT04662580, titled "ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer." The trial is a Phase 1 study with an enrollment of 183 participants, conducted in the United States, and is currently active but not recruiting.
Yes, the ARX517 clinical trial is biomarker-selected, meaning participants are chosen based on specific biological markers. The study enrolls adult male patients aged 18 years and older with metastatic prostate cancer and does not include healthy volunteers.