RecruitingPhase 1Phase 2NCT06600698

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)


Sponsor

Milton S. Hershey Medical Center

Enrollment

45 participants

Start Date

May 7, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called AGN-INM176 in men with prostate cancer whose PSA (a blood marker for prostate cancer) is rising, to evaluate its safety and effectiveness. **You may be eligible if...** - You are a male aged 40 or older - You have a history of prostate cancer - You have been treated with surgery, radiation, or hormone therapy, OR you have low-risk or intermediate-risk localised prostate cancer that you chose not to treat - You are not currently receiving radiation therapy or hormone therapy (androgen deprivation therapy) - You have good overall health (performance status 0–2) and normal liver and kidney function - You and your partner agree to use two methods of contraception during the study **You may NOT be eligible if...** - You are currently receiving hormone therapy or radiation for prostate cancer - You have abnormal liver, kidney, or blood count results at baseline - You do not meet the study's performance status criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGINM176

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.


Locations(1)

Penn State Cancer Institute

Hershey, Pennsylvania, United States

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NCT06600698


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