Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06206876
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-12-06
Brief Title:
FL118 for Treating Patients With Advanced Pancreatic Ductal Adenocarcinoma
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
First-in-Human Phase I Trial of FL118 in Patients With Advanced Pancreatic Ductal Adenocarcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
This phase I trial tests the safety side effects and best dose of FL118 in treating patients with pancreatic ductal adenocarcinoma that may have spread from where it first started to nearby tissue lymph nodes or distant parts of the body advanced FL118 is a small anti-tumor molecule that inhibits the expression of multiple cancer-associated anti-apoptotic proteins An anti-apoptotic protein is a protein that interferes with or inhibits cell death In adults apoptosis is used to rid the body of cells that have been damaged beyond repair Apoptosis also plays a role in preventing cancer If apoptosis is for some reason prevented it can lead to uncontrolled cell production that can subsequently develop into a tumor FL118 has been shown to inhibit or block the proteins that prevent damagedmutated genetically changed cells from dying and by doing so prevent the growth of cancerous cells and tumor development
Detailed Description:
PRIMARY OBJECTIVES
I To establish the safety schedule and dosing of DDX5 degrader FL118 FL118 in patients with advanced pancreatic ductal adenocarcinoma PDAC
II To determine the pharmacokinetics PK of FL118 in patients with advanced PDAC
SECONDARY OBJECTIVES
I To determine the pharmacodynamics PD of FL118 in patients with advanced PDAC
II To determine the preliminary antineoplastic efficacy of FL118 in patients with advanced PDAC
EXPLORATORY OBJECTIVES
I To evaluate biomarkers predictive of response or resistance II Evaluate changes in the tumor microenvironment III To determine the significance of somatic and germline DNA damage repair mutations as predictive biomarkers of antineoplastic activity
OUTLINE This is a dose-escalation study of FL118 followed by a dose-expansion study
Patients receive FL118 orally PO on days 1 8 and 15 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo collection of blood samples and computed tomography CT or magnetic resonance imaging MRI throughout the trial Patients may optionally undergo biopsy at screening and on study
After completion of study treatment patients are followed up at 30 days and then every 3 months for up to 12 months
I To establish the safety schedule and dosing of DDX5 degrader FL118 FL118 in patients with advanced pancreatic ductal adenocarcinoma PDAC
II To determine the pharmacokinetics PK of FL118 in patients with advanced PDAC
SECONDARY OBJECTIVES
I To determine the pharmacodynamics PD of FL118 in patients with advanced PDAC
II To determine the preliminary antineoplastic efficacy of FL118 in patients with advanced PDAC
EXPLORATORY OBJECTIVES
I To evaluate biomarkers predictive of response or resistance II Evaluate changes in the tumor microenvironment III To determine the significance of somatic and germline DNA damage repair mutations as predictive biomarkers of antineoplastic activity
OUTLINE This is a dose-escalation study of FL118 followed by a dose-expansion study
Patients receive FL118 orally PO on days 1 8 and 15 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo collection of blood samples and computed tomography CT or magnetic resonance imaging MRI throughout the trial Patients may optionally undergo biopsy at screening and on study
After completion of study treatment patients are followed up at 30 days and then every 3 months for up to 12 months
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-08681 | REGISTRY | None | None |
| I 3555023 | OTHER | Roswell Park Cancer Institute | None |