NCT05395260

FL- 101 Study in Non-Metastatic MIBC

A Pilot Window of Opportunity Trial: FL-101 in Non-Metastatic Muscle Invasive Bladder Cancer

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Flame Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Muscle Invasive Bladder Carcinoma

Interventions

Type	Name	Description
DRUG	FL-101	FL-101 200mg IV

Timeline

• Start date: 2022-08-22
• Primary completion: 2022-11-28
• Completion: 2022-12-28
• First posted: 2022-05-27
• Last updated: 2022-08-19

Regulatory

• FDA-regulated drug study