drugset / Trial / NCT06600698

Safety and Efficacy of AGN-INM176 in Prostate Patients With Rising PSA

NCT06600698

Phase 1/2 Recruiting 45 enrolled Milton S. Hershey Medical Center
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

EvaluationDrugModalityDoseRoute
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

Indications