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

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT06600698
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INM176 — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 7, 2025
Status verified
Apr 2026
Primary completion
May 1, 2027
Completion
May 1, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: INM176 Dose Escalation and Tolerability Assessment in phase I and efficacy assessment in phase II
    Phase I evaluates the safety and tolerability of INM176 using a dose escalation design. Participants will receive INM176 at the following dose levels: Dose Level -1 (400 mg/day), Dose Level 0 (800 mg/day), Dose Level +1 (1200 mg/day), and Dose Level +2 (1600 mg/day). The trial starts with 3 subjects at Dose Level 0. If none experience dose-limiting toxicity (DLT), 3 more subjects will be escalated to Dose Level +1. If one subject at Dose Level 0 experiences DLT, 3 additional subjects will be enrolled at the same level. Dose Level -1 is considered the maximum tolerated dose if 2 or more of 6 subjects experience DLT at Dose Level 0. The recommended Phase II dose (RP2D) may be the MTD or Dose Level +2 if no DLT is observed. Phase II measures changes in Prostate-Specific Antigen (PSA) levels from baseline to after 6 cycles of treatment at the Recommended Phase II Dose (RP2D). PSA level declines from baseline or stays same will be recorded as a positive responder to INM176.

Primary Outcome Measure

Safety of INM176 after 1, 2, 3,4, 5, and 6 cycles of exposure at RP2D [ Time Frame: 10 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Cancer InstituteHersheyPennsylvania17033
Monika Joshi, MD
[email protected]
7175318678

Find similar trials in Hershey, PA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Penn State Cancer Institute· Hershey, PA

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