Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04662580 | ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 183 | — | — | May 3, 2021 | Dec 31, 2026 | Jun 5, 2026 | 12 | United States |
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...