drugset / Trial / NCT02866916
Study of SXL01 in Patients With Metastatic Castration-Resistant Prostate Cancer (PROSTIRNA)
NaSingle-groupOpen-labelTreatment
Summary
This is a single site, open-label, non-randomized, dose escalation phase I study designed to evaluate the safety, the tolerability and the Recommended Phase II Dose (RP2D) of SXL01, a synthetic small interfering ribonucleic acid (RNA) targeting the androgen receptor messenger RNA (mRNA), in patients with metastatic castration-resistant prostate cancer. A standard method "3+3" will be used for dose escalation. A maximum of 30 patients will complete the dose-escalation phase of the study; 12 additional patients will be included at the RP2D in the expansion phase.
Timeline
- Start
- 2017-09
- Primary completion
- 2020-06
- Completion
- 2020-06
Outcome
Outcome not reported
Stopped: “Study cancelled”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SXL01 | Small interfering RNA (siRNA) | — | Subcutaneous |