Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:42 PM
Study NCT ID:
NCT05395260
Status:
WITHDRAWN
Last Update Posted:
2022-08-19
First Post:
2022-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FL- 101 Study in Non-Metastatic MIBC
Sponsor:
Flame Biosciences
Organization:
Study Overview
Official Title:
A Pilot Window of Opportunity Trial: FL-101 in Non-Metastatic Muscle Invasive Bladder Cancer
Status:
WITHDRAWN
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A pilot window of opportunity study of FL-101 in patients with non-metastatic MIBC who are eligible for radical cystectomy (RC) but are ineligible for, or decline, cisplatin-based neoadjuvant therapy.
Detailed Description:
This is a pilot window of opportunity study of FL-101 in patients with non-metastatic MIBC who are eligible for radical cystectomy (RC) but are ineligible for, or decline, cisplatin-based neoadjuvant therapy.
The target recruitment will be 5 evaluable patients, with a possible expansion. Eligible patients will be enrolled to receive two doses of FL-101 prior to RC. FL-101 will be administered intravenously (IV) every two weeks (i.e., on Day 1 and Day 15).
Safety will be assessed by monitoring and recording all TEAEs graded by the NCI CTCAE v.5.0. In addition, laboratory assessments (hematology, serum chemistry, coagulation, and urinalysis), vital signs, physical exams, and 12-lead electrocardiogram (ECG) findings will be used to evaluate the safety of FL-101.
The PK of FL-101 will be characterized by analyzing samples collected at the time points.
To assess the immunogenicity of FL-101, ADAs will be measured as indicated in the Schedule of Assessments.
The target recruitment will be 5 evaluable patients, with a possible expansion. Eligible patients will be enrolled to receive two doses of FL-101 prior to RC. FL-101 will be administered intravenously (IV) every two weeks (i.e., on Day 1 and Day 15).
Safety will be assessed by monitoring and recording all TEAEs graded by the NCI CTCAE v.5.0. In addition, laboratory assessments (hematology, serum chemistry, coagulation, and urinalysis), vital signs, physical exams, and 12-lead electrocardiogram (ECG) findings will be used to evaluate the safety of FL-101.
The PK of FL-101 will be characterized by analyzing samples collected at the time points.
To assess the immunogenicity of FL-101, ADAs will be measured as indicated in the Schedule of Assessments.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: