drugset / Trial / NCT06600698
Safety and Efficacy of AGN-INM176 in Prostate Patients With Rising PSA
NaSequentialOpen-labelTreatment
Summary
This Phase I/II open-label trial aims to evaluate the safety and efficacy of the herbal supplement INM176 in patients with a history of prostate cancer or low-risk disease under active surveillance. The study will determine the recommended Phase II dose (RP2D) and assess the efficacy of INM176 in stabilizing or decreasing plasma PSA levels in post-radical prostatectomy (RP) and post-radiation therapy (RT) patients with rising PSA levels.
Timeline
- Start
- 2025-05-07
- Primary completion
- 2027-05-01
- Completion
- 2028-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | INM176 | Traditional medicine (herbal / TCM) | 400 mg | Oral |
| Subject | INM176 | Traditional medicine (herbal / TCM) | 800 mg | Oral |
| Subject | INM176 | Traditional medicine (herbal / TCM) | 1200 mg | Oral |
| Subject | INM176 | Traditional medicine (herbal / TCM) | 1600 mg | Oral |