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FL- 101 Study in Non-Metastatic MIBC

NCT05395260 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2022-08-19

No results posted yet for this study

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.

Conditions

  • Muscle Invasive Bladder Carcinoma

Interventions

DRUG

FL-101

FL-101 200mg IV

Sponsors & Collaborators

  • Flame Biosciences

    lead INDUSTRY

Principal Investigators

  • Matthew Galsky, MD · Icahn School of Medicine at Mount Sinai

  • Sumanta Kumar Pal, MD · City of Hope Comprehensive Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2022-11-28
Completion
2022-12-28
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05395260 on ClinicalTrials.gov