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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the herbal supplement INM176 to determine if it can safely help manage prostate cancer. Researchers aim to find the optimal dose and assess whether it can stabilize or reduce PSA levels, markers used to track prostate cancer, in patients who have undergone surgery or radiation but still experience rising PSA levels. Men with a history of prostate cancer who are not currently receiving treatments like radiation or hormone therapy may be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications, especially if they interact with the study drug. Essential medications like statins might be allowed, but herbal supplements containing AGN extract must be stopped at least 4 weeks before starting the trial. It's best to discuss your specific medications with the trial investigator.

Is there any evidence suggesting that INM176 is likely to be safe for humans?

Research has shown that INM176 is being tested for safety in people with prostate cancer. In this ongoing study, researchers are trying different doses to assess how well participants tolerate the treatment. The doses range from 400 mg to 1600 mg per day.

As this trial is in its early stages, the main goal is to evaluate the treatment's safety for humans. Being a Phase I/II trial, safety remains a primary concern. There is limited information about side effects at this stage. However, the treatment's progression to this phase indicates some initial confidence in its safety from earlier research.

Participants in this trial will help determine the best dose that balances effectiveness and safety, an important step in ensuring INM176 can be safely used by more people in the future. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about INM176 for prostate cancer because it offers a potentially novel approach compared to existing treatments like hormone therapy, chemotherapy, or radiation. Unlike these standard options that often target the entire body, INM176 is designed to specifically target prostate cancer cells, potentially leading to fewer side effects. The treatment is administered in varying doses to determine the most effective and safest level, focusing on reducing Prostate-Specific Antigen (PSA) levels, an important marker in prostate cancer management. This targeted approach could mean more precise treatment outcomes and improved quality of life for patients.

What evidence suggests that INM176 might be an effective treatment for prostate cancer?

Research has shown that INM176, a herbal supplement, might help manage prostate cancer by stabilizing or lowering PSA levels. PSA, or Prostate-Specific Antigen, is a protein produced by prostate cells, and high levels can indicate cancer activity. Early findings suggest that INM176 can reduce PSA levels, which is promising for those whose PSA levels rise after treatments like surgery or radiation. This trial will evaluate the safety and tolerability of INM176 through a dose escalation design in Phase I and measure changes in PSA levels in Phase II to determine its efficacy. Initial research focuses on finding the right dosage and ensuring it is safe for patients. ^{1 4 6 7 8}

Who Is on the Research Team?

Monika Joshi, MD

Principal Investigator

Penn State Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06600698?cond=Angelica%20archangelica&viewType=Table&rank=9

Safety and Efficacy of AGN-INM176 in Prostate Patients ... 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 ...

2. withpower.com withpower.com/trial/inm176-for-prostate-cancer-33bc1

INM176 for Prostate Cancer 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 ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/condition/921/urologic-cancer?page=16

Urologic Cancer Clinical Research Trials 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12031432/

Vaccination Against RhoC in Prostate Cancer Patients ... Vaccination Against RhoC in Prostate Cancer Patients Induces Potent and Long-Lasting CD4+ T Cell Responses with Cytolytic Potential in the ...

5. synapse.patsnap.com synapse.patsnap.com/drug/0c61979ff6014f7eabd69d71a0d5c5ec

INM-176 - Drug Targets, Indications, Patents RESULTS: Scopolamine-induced cognitive dysfunction was significantly attenuated by a single or sub-chronic administration of INM-176 in the passive avoidance ...

6. trialx.com trialx.com/clinical-trials/listings/309766/safety-and-efficacy-of-agn-inm176-in-prostate-patients-with-rising-psa/

Safety and Efficacy of AGN-INM176 in Prostate Patients ... 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 ...

7. clin.larvol.com clin.larvol.com/trial-detail/NCT06600698

Safety and Efficacy of AGN-INM176 in Prostate Patients ... The degree of PSA reduction will serve as an indicator of INM176's effectiveness in controlling or reducing prostate cancer activity. 10 months. Maximum ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05375539

Study Details | NCT05375539 | AGN-CognI.Q Acute Dose ... This study is to obtain acute dose safety and pharmacokinetics/pharmacodynamics (PK/PD) data in a dose-response trial in prostate cancer patients. Detailed ...