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

  • Not Yet Recruiting
  • Treatment
  • Interventional
  • Drug
  • PHASE1/PHASE2
  • Milton S. Hershey Medical Center
  • 40 Years -


Study Purpose

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.

Intervention

Drug : INM176


Eligibility Requirements

info icon Phase I Inclusion Criteria

info icon Willingness and ability to give informed consent.

info icon Agree to comply with all study procedures and attend all study visits to the best of their ability.

info icon Male aged \>=40 years.

info icon History of prostate cancer diagnosis. Subjects with history of neuroendocrine or small cell prostate cancer will be excluded. Subjects are eligible if they meet one or more of the below criteria:

info icon 4a. Subjects with treated prostate cancer are eligible. 4b. Subjects with localized prostate cancer in low-risk group who were not on treatment or declined any treatment are eligible.

info icon 4c. Subjects with localized prostate cancer in the favorable intermediate-risk group who declined any treatment are eligible.

info icon Subjects must not be undergoing concurrent radiation therapy or androgen deprivation therapy (ADT) at the time of enrollment.

info icon ECOG performance status 0-2. 7. Subjects must have normal liver and kidney function as defined below:

info icon a) total bilirubin within normal institutional limits,

info icon b) AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal,

info icon c) Creatinine within 1.5 ULN of institutional limits OR creatinine clearance \> 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.

info icon d) Adequate bone marrow function (Hgb ≥ 9.0 g/dL, Platelets ≥ 100 x 109/L, absolute neutrophil count of ≥ 1.0 x 109/L). 8. Subjects and their partners must agree to use two medically accepted methods of contraception and must agree to continue use these methods during the trial and for at least one week after the last dose of study drug. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD) known to have a failure rate of less than 1% per year, or steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) withdrawal, spermicides only, or lactational amenorrhea are not acceptable methods of contraception. 9. Subjects taking strong inhibitors or inducers of CYP3A4 or CYP2C19 must be evaluated for potential drug interactions with the study drug. Essential medications, such as statins, that cannot be discontinued may be allowed if deemed safe and appropriate by the investigator, or if an alternative medication can be substituted. 10. Subjects currently taking herbal supplements containing AGN extract, such as Cogni.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin, must discontinue these or any other supplements containing these products 4 weeks prior to starting study drug. * Phase II Inclusion Criteria

info icon Willingness and ability to give informed consent.

info icon Agree to comply with all study procedures and attend all study visits to the best of their ability.

info icon Male aged \>=40 years.

info icon Histologically confirmed adenocarcinoma of Prostate. Subjects with history of neuroendocrine or small cell prostate cancer must be excluded.

info icon Any T stage, N0-1, M0, any Gleason grade.

info icon Subjects with treated prostate cancer, either post-radical prostatectomy (RP) or post-radiation therapy (RT). Subjects who have local recurrence in the prostate after treatment but decline further intervention are also eligible.

info icon OR Subjects with localized prostate cancer (no distant or nodal metastases) who have declined any treatment after discussion with their treating physician.

info icon No distant metastases disease confirmed by imaging (CT or MRI and bone scan or prostate-specific PET scan such as PSMA PET scan or Axumin PET scan).

info icon Blood PSA level rising over 2 consecutive tests within the past 6 months, at least one week apart.

info icon Not currently receiving concurrent androgen deprivation therapy, and testosterone levels should be within a non-castrate range (normal or at least \>50 ng/dL).

info icon ECOG performance status 0-2.

info icon Subjects must have normal liver and kidney function as defined below: 1. total bilirubin within normal institutional limits, 2. AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal (ULN), 3. Creatinine within 1.5 ULN of institutional limits OR creatinine clearance \> 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal, 4. Adequate bone marrow function (Hgb ≥ 9.0 g/dL, Platelets ≥ 100 x 109/L, absolute neutrophil count of ≥ 1.0 x 109/L).

info icon No evidence of any active secondary malignancy requiring ongoing treatment.

info icon Subjects must agree to use two medically accepted method of contraception and must agree to continue use this method while on the trial and through at least one week after the last dose of study drug. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD) known to have a failure rate of less than 1% per year, or steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) withdrawal, spermicides only, or lactational amenorrhea are not acceptable methods of contraception.

info icon Subjects taking strong inhibitors or inducers of CYP3A4 or CYP2C19 must be evaluated for potential drug interactions with the study drug. Essential medications, such as statins, that cannot be discontinued may be allowed if deemed safe and appropriate by the investigator, or if an alternative medication can be substituted.

info icon Subjects currently taking herbal supplements containing AGN extract, including Cogni.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin must discontinue these or any other supplements containing these products 4 weeks prior to starting study drug.

info icon Minimum age: 40

info icon Subjects with distant metastatic cancer. Node-positive prostate cancer patients are allowed after completion of treatment.

info icon Subjects who are receiving systemic treatments such as chemotherapy, androgen deprivation therapy (ADT) or anti-androgen therapy including LHRH agonist, antagonist, GNRH analogs, and antiandrogens, or immunotherapy (checkpoint inhibitor).

info icon Subjects who are receiving any other investigational agents. Participants will be excluded if they have any uncontrolled intercurrent illness at the discretion of the treating investigator. This may include, but is not limited to, the following conditions: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus (DM) with an HbA1C \>9, uncontrolled asthma, or psychiatric illness/social situations that would limit compliance with study requirements.

info icon History of New York Heart Association Class III or IV heart failure, history of a myocardial infarction within 6 months, or any other cardiac-related problem that would be considered a contraindication for participation in the opinion of the treating physician.

info icon Any active secondary malignancy requiring treatment.

info icon Chronic kidney disease with calculated GFR \<30 mL/min/1.73 m2 using Cockcroft-Gault formula, or measured GFR \<30 mL/min/1.73 m2 using a 24-hour urine collection. The hospital's lab measured GFR can be used if a 24-hour collection is not possible.

info icon Subjects who are taking Warfarin/coumadin.

Recruiting status

Not Yet Recruiting

Estimated enrollment

45

 
Study start date

Mar 01, 2025

Study end date

Jan 01, 2028

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug

Study phase

PHASE1/PHASE2

Allocation

Na

 

Sponsor:

Milton S. Hershey Medical Center

Collaborator:

N/A

Investigator:

Monika Joshi, MD

NCT06600698

Clinic Location Investigator Distance RECRUITING STATUS Contact