drugset / Trial / NCT07553988
A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of the study is to determine the therapeutic dose of RS-113 in patients with metastatic castration-resistant prostate cancer based on efficacy, safety, and pharmacokinetic parameters. The secondary objectives are to assess a pilot efficacy and safety of different doses of RS-113 versus abiraterone, as well as to investigate pharmacokinetics profile and to perform a pilot evaluation of pharmacokinetics parameters of RS-113 in patients with metastatic castration-resistant prostate cancer
Timeline
- Start
- 2024-10-24
- Primary completion
- 2026-05-14
- Completion
- 2027-05-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abiraterone acetate | Small molecule | 1000 mg | — |
| Comparator | Prednisolone | Other / unclassified | 10 mg | — |
| Subject | RS-113 | Unknown | 160 mg | Oral |
| Subject | RS-113 | Unknown | 240 mg | Oral |
| Subject | RS-113 | Unknown | 320 mg | Oral |
| Background | Goserelin | Other / unclassified | 3.6 mg | Subcutaneous |
| Background | Goserelin | Other / unclassified | 10.8 mg | Subcutaneous |
| Background | Leuprolide | Other / unclassified | 7.5 mg | Subcutaneous |
| Background | Leuprolide | Other / unclassified | 22.5 mg | Subcutaneous |
| Background | Triptorelin | Other / unclassified | 3.75 mg | Intramuscular |
| Background | buserelin | Unknown | 3.75 mg | Intramuscular |