Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600698
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Safety and Efficacy of AGN-INM176 in Prostate Patients With Rising PSA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluate Safety and Efficacy of Daily Oral Angelica Gigas Nakai AGN-INM176 in Prostate Patients With Rising Plasma PSA Phase III Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase III 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 III 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 33 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 pharmacokinetics PK analysis on the first and last doses of Cycle 1 correlating PK metrics to safety and efficacy outcomes stratified by CYP2C19 and 3A4 metabolizer status Additional secondary measures involve assessing PSA changes immunophenotyping of blood natural killer NK cells NK functional activity cytokine levels and hormone-binding proteins all analyzed as pharmacodynamic PD biomarkers These results will inform the design of future large-scale randomized controlled trials RCTs investigating the efficacy of INM176 in delaying or preventing prostate cancer recurrence
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 pharmacokinetics PK analysis on the first and last doses of Cycle 1 correlating PK metrics to safety and efficacy outcomes stratified by CYP2C19 and 3A4 metabolizer status Additional secondary measures involve assessing PSA changes immunophenotyping of blood natural killer NK cells NK functional activity cytokine levels and hormone-binding proteins all analyzed as pharmacodynamic PD biomarkers These results will inform the design of future large-scale randomized controlled trials RCTs investigating the efficacy of INM176 in delaying or preventing prostate cancer recurrence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None