Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06217094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-01-10
Brief Title:
Study of NP-101 in Patients With Unresectable Hepatocellular Carcinoma HCC Undergoing Y-90 Treatment
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Phase I Study of NP-101 in Patients With Unresectable Hepatocellular Carcinoma HCC Undergoing Y-90 Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Surgical resection and liver transplantation are the primary curative treatments for hepatocellular carcinoma HCC However many patients are ineligible for these treatments due to advanced disease social factors or limited availability of liver donors Therefore for patients with unresectable HCC locoregional therapies like transarterial radioembolization TARE with Y90 are considered the next best non-operative option especially when the cancer remains confined to the liver Despite the use of these liver-directed therapies relapse rates and mortality remain high underscoring the need for new predictive biomarkers and therapeutic targets including immune modulation
The rationale behind NP-101 TQ formula stems from its immune modulatory properties as a potent drug derived from a natural substance black seed or Nigella Sativa Previous studies have demonstrated its immune modulation and anti-cancer effects showing promise in preclinical models of HCC In a randomized phase 2 study conducted in Covid patients NP-101 exhibited safety and significantly increased T effector cells CD4 and CD8 T lymphocytes resulting in accelerated recovery The immune modulation effect of NP-101 observed in the Covid study and its potential to enhance CD4 and CD8 T effector lymphocytes can potentially modify the immune microenvironment and improve outcomes in locally advanced HCC patients undergoing Y90 treatment
This study will investigate the safety efficacy and maximum tolerated dose of NP-101 in patients with unresectable hepatocellular carcinoma
The dosing scheme for NP-101 in this study will follow a Bayesian Optimal Interval design Based on the target dose-limiting toxicity DLT rate of 30 and assuming a 33 design three subjects will be sequentially enrolled at each of the 3 dose levels beginning with 3g until at least one DLT occurs
If no DLTs occur dosing will be escalated to the next dose level for the next three enrolled subjects At either of the two dose levels if 1 DLT occurs three more subjects will be enrolled at that dose level If no DLTs occur in these subjects three more subjects will be enrolled at the next highest dose level Dosing escalation will be stopped if two or more total DLTs occur at any dose level The maximum tolerated dose MTD will be one dose level below the dose level at which two or more DLTs occurred
The rationale behind NP-101 TQ formula stems from its immune modulatory properties as a potent drug derived from a natural substance black seed or Nigella Sativa Previous studies have demonstrated its immune modulation and anti-cancer effects showing promise in preclinical models of HCC In a randomized phase 2 study conducted in Covid patients NP-101 exhibited safety and significantly increased T effector cells CD4 and CD8 T lymphocytes resulting in accelerated recovery The immune modulation effect of NP-101 observed in the Covid study and its potential to enhance CD4 and CD8 T effector lymphocytes can potentially modify the immune microenvironment and improve outcomes in locally advanced HCC patients undergoing Y90 treatment
This study will investigate the safety efficacy and maximum tolerated dose of NP-101 in patients with unresectable hepatocellular carcinoma
The dosing scheme for NP-101 in this study will follow a Bayesian Optimal Interval design Based on the target dose-limiting toxicity DLT rate of 30 and assuming a 33 design three subjects will be sequentially enrolled at each of the 3 dose levels beginning with 3g until at least one DLT occurs
If no DLTs occur dosing will be escalated to the next dose level for the next three enrolled subjects At either of the two dose levels if 1 DLT occurs three more subjects will be enrolled at that dose level If no DLTs occur in these subjects three more subjects will be enrolled at the next highest dose level Dosing escalation will be stopped if two or more total DLTs occur at any dose level The maximum tolerated dose MTD will be one dose level below the dose level at which two or more DLTs occurred
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OCR44171 | OTHER | University of Florida | None |