Prostate CancerPhase 1/2NCT06600698
Safety and Efficacy of AGN-INM176 in Prostate Patients With Rising PSA
A Phase 1/2 study testing INM176 in people with Prostate Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- INM176
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2025to 31 Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase I Inclusion Criteria
- 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.
- Subjects must not be undergoing concurrent radiation therapy or androgen deprivation therapy (ADT) at the time of enrollment.
Show all 36Show fewer
- ECOG performance status 0-2.
- Subjects must have normal liver and kidney function at baseline: Total bilirubin within normal institutional limits. AST(SGOT)/ALT(SGPT) < 2.5 X upper limit of normal (ULN). Creatinine < 1.5 ULN or creatinine clearance > 50 mL/min/1.73 m2. Adequate bone marrow function: Hgb ≥ 9.0 g/dL, Platelets ≥ 100 x 109/L, absolute neutrophil count of ≥ 1.0 x 109/L).International Normalized Ratio (INR), Prothrombin Time (PT), and Partial Thromboplastin Time (PTT)within normal institutional limits.
- 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.
- 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 at the investigator's discretion.
- Subjects currently taking herbal supplements containing AGN extract, such as Cogni.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, must discontinue these or any other supplements containing these products at least 4 weeks prior to starting study drug.
- Phase II Inclusion Criteria
- Willingness and ability to give informed consent.
- Agree to comply with all study procedures and attend all study visits.
- Male aged >=40 years.
- Histologically confirmed adenocarcinoma of prostate (neuroendocrine or small cell prostate cancer excluded).
- Any T stage, N0-1, M0, any Gleason grade.
- Subjects must meet one of the following: Post-radical prostatectomy (RP) and/or post-radiation therapy (RT), including those with local recurrence declining further treatment. Localized prostate cancer who declined any treatment after physician discussion. Non-castrate status required: eligible subjects must have a serum total testosterone >50 ng/dL measured within 6 months prior to enrollment and must not have received systemic ADT (LHRH agonist/antagonist) within the prior 6 months. Subjects with bilateral orchiectomy are ineligible.
- 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) within 5 years prior to enrollment.
- Blood PSA level rising over 2 consecutive tests within the past 6 months, at least one week apart, with values ≥ 0.1 ng/mL.
- Not currently receiving concurrent androgen deprivation therapy (ADT). For subjects with a prior history of ADT, screening testosterone levels must be obtained and must be within a non-castrate range (>50 ng/dL) to be eligible for Phase II. Subjects without a history of ADT are not required to undergo testosterone screening.
- ECOG performance status 0-2.
- Subjects must have normal liver, kidney, and bone marrow function at baseline: Total bilirubin within institutional limits. AST(SGOT)/ALT(SGPT) < 2.5 X upper limit of normal (ULN). Creatinine < 1.5 ULN or creatinine clearance > 50 mL/min/1.73 m2. Adequate bone marrow function: Hgb ≥ 9.0 g/dL, Platelets ≥ 100 x 109/L, absolute neutrophil count ≥ 1.0 x 109/L.
- No evidence of any active secondary malignancy requiring ongoing treatment.
- 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.
- Subjects taking strong inhibitors or inducers of CYP3A4 or CYP2C19 will be evaluated for potential drug interactions with the study drug. Essential medications, such as statins, that cannot be discontinued may be allowed at the investigator's discretion.
- Subjects currently taking herbal supplements containing AGN extract, including Cogni.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, must discontinue these or any other supplements containing these products at least 4 weeks prior to starting study drug.
- Prior Phase I subjects: must have completed ≥90 days washout from the last investigational product dose and meet all of the following: No treatment-related Grade 3 or higher adverse events occurred during Phase I, Any treatment-related adverse events have resolved to Grade 1 or less prior to Phase II enrollment, hepatic and renal function tests within protocol-defined limits, and investigator confirmation of clinical stability.
- Phase I and II Exclusion Criteria:
- 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.
- Any active secondary malignancy requiring treatment.
- Chronic kidney disease with calculated GFR <30 mL/min/1.73 m(2) using Cockcroft-Gault formula, or measured GFR <30 mL/min/1.73 m(2) using a 24-hour urine collection. The hospital's lab measured GFR can be used if a 24-hour collection is not possible.
- Subjects who are taking Warfarin/coumadin.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State Cancer Institute
Hershey, Pennsylvania, 17033
Monika Joshi, MD, 717-531-8678, mjoshi@pennstatehealth.psu.edu
About this study
Official title: Evaluate Safety and Efficacy of Daily Oral Angelica Gigas Nakai (AGN)-INM176 in Prostate Patients With Rising Plasma PSA (Phase I/II 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.
Read the detailed description
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 cancer-specific PSA levels. The primary objective of the Phase I stage is to determine the recommended Phase II dose (RP2D) through a 3+3 dose escalation design while evaluating the safety of INM176 during a 4-week cycle for dose-limiting toxicities (DLTs) in patients with a history of prostate cancer or those under active surveillance for low-risk disease.
In the Phase II stage, the primary objective is to evaluate the efficacy of INM176 at the RP2D in stabilizing or reducing plasma PSA levels after six cycles of treatment in post-RP and post-RT patients experiencing a rise in PSA.
Secondary objectives include pharmacokinetic (PK) evaluations following the first dose (Cycle 1 Day 1) in both Phase I and Phase II subjects, with an additional PK assessment on Cycle 1 Day 28 for Phase I subjects and on Cycle 2 Day 1 for Phase II subjects. Acute and chronic exposure PK parameters (including Cmax and AUC) will be correlated with safety outcomes and prostate-specific antigen (PSA) efficacy measures, when applicable, stratified by CYP2C19 and CYP3A4 metabolizer status.
Additional secondary objectives include evaluation of PSA change from baseline at protocol-specified timepoints; immunophenotyping of blood natural killer (NK) cells and other immune cell subsets; assessment of NK functional activity, plasma IL-8, and select cytokines; and measurement of male hormones and hormone-binding proteins. These pharmacodynamic biomarkers will be analyzed in relation to PSA response and PK metrics, with assessments conducted according to Phase I and Phase II study schedules.
- Conditions
- Prostate Cancer
- Being tested
- INM176
- Keywords
- Angelica gigas Nakai, INM 176, Pharmacokinetics, Decursin, decursinol, prostate specific antigen (PSA)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INM176Drug
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 group | Role | What they receive |
|---|---|---|
| INM176 Dose Escalation and Tolerability Assessment in phase I and efficacy assessment in phase II | Experimental | 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. Receives: Drug: INM176 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months
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.
Measured: 10 months
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.
Measured: 28 days
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.
Measured: 28 days
Dose-Limiting Toxicities (DLTs)
Dose-Limiting Toxicities (DLTs) are defined as adverse events or laboratory abnormalities that are considered to be related to the study treatment and occur during the first treatment cycle (28 days). DLTs will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The occurrence of DLTs will guide dose escalation decisions and help identify the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 May 2025
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This is a one-arm, sequential Phase I/II study to evaluate INM176. Phase I uses a 3+3 dose escalation design to find the recommended Phase 2 dose (RP2D) based on dose-limiting toxicities. Phase II includes two stages: Stage 1 involves 13 subjects to test early efficacy; if ≥1 responds (PSA decline/stabilization), the study moves to Stage 2. Stage 2 enrolls 14 more subjects (total 27) to assess efficacy. A PSA response rate \>5% is declared if ≥4 subjects show response. Safety and efficacy will be evaluated with descriptive statistics, linear mixed-effects models, and regression analyses for PK and biomarkers. Intervention Type: Drug
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junxuan Lu, Milton S. Hershey Medical Center
- Investigators
- Monika Joshi, MD, Principal investigator, Penn State Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600698
- Sponsor's protocol ID
- PSCI-24-010
- Status last verified
- Aug 2026
- First submitted
- 13 Sep 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Safety and Efficacy of Daily Oral Angelica Gigas Nakai (AGN)-INM176 in Prostate Patients With Rising Plasma PSA (Phase I/II Trial)
- ClinicalTrials.gov ID
- NCT06600698
- Acronym / sponsor ID
- PSCI-24-010
- Conditions
- Prostate Cancer
- Keywords
- Angelica gigas Nakai, INM 176, Pharmacokinetics, Decursin, decursinol, prostate specific antigen (PSA)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 cancer-specific PSA levels. The primary objective of the Phase I stage is to determine the recommended Phase II dose (RP2D) through a 3+3 dose escalation design while evaluating the safety of INM176 during a 4-week cycle for dose-limiting toxicities (DLTs) in patients with a history of prostate cancer or those under active surveillance for low-risk disease.
In the Phase II stage, the primary objective is to evaluate the efficacy of INM176 at the RP2D in stabilizing or reducing plasma PSA levels after six cycles of treatment in post-RP and post-RT patients experiencing a rise in PSA.
Secondary objectives include pharmacokinetic (PK) evaluations following the first dose (Cycle 1 Day 1) in both Phase I and Phase II subjects, with an additional PK assessment on Cycle 1 Day 28 for Phase I subjects and on Cycle 2 Day 1 for Phase II subjects. Acute and chronic exposure PK parameters (including Cmax and AUC) will be correlated with safety outcomes and prostate-specific antigen (PSA) efficacy measures, when applicable, stratified by CYP2C19 and CYP3A4 metabolizer status.
Additional secondary objectives include evaluation of PSA change from baseline at protocol-specified timepoints; immunophenotyping of blood natural killer (NK) cells and other immune cell subsets; assessment of NK functional activity, plasma IL-8, and select cytokines; and measurement of male hormones and hormone-binding proteins. These pharmacodynamic biomarkers will be analyzed in relation to PSA response and PK metrics, with assessments conducted according to Phase I and Phase II study schedules.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a one-arm, sequential Phase I/II study to evaluate INM176. Phase I uses a 3+3 dose escalation design to find the recommended Phase 2 dose (RP2D) based on dose-limiting toxicities. Phase II includes two stages: Stage 1 involves 13 subjects to test early efficacy; if ≥1 responds (PSA decline/stabilization), the study moves to Stage 2. Stage 2 enrolls 14 more subjects (total 27) to assess efficacy. A PSA response rate >5% is declared if ≥4 subjects show response. Safety and efficacy will be evaluated with descriptive statistics, linear mixed-effects models, and regression analyses for PK and biomarkers. Intervention Type: Drug
| Arm | Type | Receives |
|---|---|---|
| INM176 Dose Escalation and Tolerability Assessment in phase I and efficacy assessment in phase II | Experimental | Drug: INM176Phase 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 may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Phase I Inclusion Criteria
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INM176The 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. | Drug | INM176 Dose Escalation and Tolerability Assessment in phase I and efficacy assessment in phase II |
Primary outcome
Safety of INM176 after 1, 2, 3,4, 5, and 6 cycles of exposure at RP2D
Time frame: 10 months
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.
Efficacy of INM176 by Measuring PSA Level Changes After 6 Cycles of Treatment at the Recommended Phase II Dose (RP2D)
Time frame: 10 months
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.
Maximum Tolerated Dose (MTD)
Time frame: 28 days
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.
Recommended Phase II Dose (RP2D)
Time frame: 28 days
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.
Dose-Limiting Toxicities (DLTs)
Time frame: 28 days
Dose-Limiting Toxicities (DLTs) are defined as adverse events or laboratory abnormalities that are considered to be related to the study treatment and occur during the first treatment cycle (28 days). DLTs will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The occurrence of DLTs will guide dose escalation decisions and help identify the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monika Joshi, MD principal investigator
Penn State Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INM176 in people with Prostate Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystal Sowers (717-531-5471, psci-cto@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of INM176 after 1, 2, 3,4, 5, and 6 cycles of exposure at RP2D (time frame: 10 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.