INM176 for Prostate Cancer

Overseen By Junxuan Lu, Ph.D

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Milton S. Hershey Medical Center

Must not be taking: Chemotherapy, Immunotherapy, Warfarin, others

Disqualifiers: Metastatic cancer, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

45 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Monika Joshi, MD

Principal Investigator

Penn State Cancer Institute

Eligibility Criteria

Men aged 40 or older with a history of treated prostate cancer, or those under active surveillance for low-risk or favorable intermediate-risk prostate cancer who haven't started treatment, can join this trial. Participants must not be on radiation therapy or hormone therapy and should have normal liver and kidney function.

Inclusion Criteria

I meet the specific requirements for the initial phase of the clinical trial.

I am willing and able to give my consent for treatment.

I am a man aged 40 years or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Participants receive INM176 in a dose escalation design to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) over a 4-week cycle

4 weeks

Weekly visits for dose escalation assessment

Phase II Treatment

Participants receive INM176 at the RP2D for 6 cycles to evaluate efficacy in stabilizing or reducing PSA levels

6 months

Monthly visits for treatment and PSA monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• INM176

Trial Overview The trial is testing the safety and effectiveness of INM176, an herbal supplement, in men whose PSA levels are rising after surgery (RP) or radiation therapy (RT) for prostate cancer. It's to find out the best dose for Phase II trials and see if it helps stabilize or lower PSA levels.

Participant Groups

Group I: INM176 Dose Escalation and Tolerability Assessment in phase I and efficacy assessment in phase II Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+