Safety and Efficacy of AGN-INM176 in Prostate Patients With Rising PSA
ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age40+
SponsorMilton S. Hershey Medical Center
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willingness and ability to give informed consent.
Agree to comply with all study procedures and attend all study visits.
Male aged >=40 years.
History of prostate cancer diagnosis: Subjects with treated prostate cancer are eligible. Prior prostate cancer treatments must be clearly defined. Acceptable treatment modalities include surgery, radiation therapy, and previous use of antiandrogen therapy. Subjects with localized prostate cancer in low-risk group who were not on treatment or declined any treatment are eligible. Subjects with localized prostate cancer in the favorable intermediate-risk group who declined any treatment are eligible. Subjects with localized prostate cancer in the high-risk or unfavorable intermediate-risk group who have declined definitive therapy, including surgery, radiation therapy, or androgen deprivation therapy (ADT), are eligible.
Disqualifiers
Subjects with distant metastatic cancer. Node-positive prostate cancer patients are allowed after completion of treatment.
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) or 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 significant psychiatric illness that would limit compliance with study requirements.
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.
Trial design
Design model
Sequential
Treatments tested in this trial
INM176
DrugThe 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.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: INM176 Dose Escalation and Tolerability Assessment in phase I and efficacy assessment in phase IIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of INM176 after 1, 2, 3,4, 5, and 6 cycles of exposure at RP2D
Safety will be assessed as the combined incidence of adverse events, abnormal safety blood tests, and abnormal ECG readings, expressed as the proportion of participants showing any of these safety concerns following 1, 2, 3, 4, 5, and 6 treatment cycles.
Time frame
10 months2
Efficacy of INM176 by Measuring PSA Level Changes After 6 Cycles of Treatment at the Recommended Phase II Dose (RP2D)
This outcome will assess the efficacy of INM176 by measuring changes in Prostate-Specific Antigen (PSA) levels from baseline to after 6 cycles of treatment at the Recommended Phase II Dose (RP2D). PSA levels will be monitored at baseline and following each treatment cycle, with a primary focus on the change observed after 6 cycles. The degree of PSA reduction will serve as an indicator of INM176's effectiveness in controlling or reducing prostate cancer activity.
Time frame
10 months3
Maximum Tolerated Dose (MTD)
The Maximum Tolerated Dose (MTD) is defined as the highest dose at which ≤1 of 6 participants experiences a dose-limiting toxicity (DLT) during Cycle 1 (28 days). Dose-limiting toxicities will be assessed according to CTCAE version 5.0.
Time frame
28 days4
Recommended Phase II Dose (RP2D)
The Recommended Phase II Dose (RP2D) will be determined based on overall safety and tolerability, observed dose-limiting toxicities, following dose escalation using a standard 3+3 design.
Time frame
28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov