NCT06600698

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

Evaluate Safety and Efficacy of Daily Oral Angelica Gigas Nakai (AGN)-INM176 in Prostate Patients With Rising Plasma PSA (Phase I/II Trial)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is designed as a Phase I/II open-label trial to assess the safety and preliminary efficacy of the herbal supplement INM176 in intercepting prostate cancer-specific PSA levels. The primary objective of the Phase I stage is to determine the recommended Phase II dose (RP2D) through a 3+3 dose escalation design while evaluating the safety of INM176 during a 4-week cycle for dose-limiting toxicities (DLTs) in patients with a history of prostate cancer or those under active surveillance for low-risk disease. In the Phase II stage, the primary objective is to evaluate the efficacy of INM176 at the RP2D in stabilizing or reducing plasma PSA levels after six cycles of treatment in post-RP and post-RT patients experiencing a rise in PSA. Secondary objectives include pharmacokinetic (PK) evaluations following the first dose (Cycle 1 Day 1) in both Phase I and Phase II subjects, with an additional PK assessment on Cycle 1 Day 28 for Phase I subjects and on Cycle 2 Day 1 for Phase II subjects. Acute and chronic exposure PK parameters (including Cmax and AUC) will be correlated with safety outcomes and prostate-specific antigen (PSA) efficacy measures, when applicable, stratified by CYP2C19 and CYP3A4 metabolizer status. Additional secondary objectives include evaluation of PSA change from baseline at protocol-specified timepoints; immunophenotyping of blood natural killer (NK) cells and other immune cell subsets; assessment of NK functional activity, plasma IL-8, and select cytokines; and measurement of male hormones and hormone-binding proteins. These pharmacodynamic biomarkers will be analyzed in relation to PSA response and PK metrics, with assessments conducted according to Phase I and Phase II study schedules.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	INM176	The active ingredient INM176 was prepared using a proprietary technology to extract AGN with ethanol and powderize with cellulose into a finished granular powder product that is 1/5 the weight of the raw herbal root. This product was chosen because its close match with the AGN extracts studied in the TRAMP model in the phytochemical profiles. It will be donated from the manufacturer Nutragen Co., Ltd. Korea.

Timeline

• Start date: 2025-05-07
• Primary completion: 2027-05-01
• Completion: 2028-05-01
• First posted: 2024-09-19
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study