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ML Risk
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 small molecule being studied for the treatment of metastatic prostate cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated as a monotherapy or in combination therapy for patients with this condition.
ARX517 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 1 clinical trials for metastatic prostate cancer.
ARX517 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The ongoing Phase 1 trial is active but not recruiting participants, and the drug is being studied for metastatic prostate cancer.
ARX517 is being studied in a Phase 1 clinical trial with the identifier NCT04662580. This trial is evaluating ARX517, also known as JNJ-95298177, as a monotherapy or combination therapy in subjects with metastatic prostate cancer. The trial is active but not recruiting and has an enrollment of 183 participants.
Yes, ARX517 is also known as JNJ-95298177. In clinical trials, the drug is referred to by both names. The Phase 1 trial NCT04662580 evaluates ARX517/JNJ-95298177 as a monotherapy or combination therapy for metastatic prostate cancer.