Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351904
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-04-02
Brief Title:
A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer NMIBC Who Have Failed Bacillus Calmette Guérin BCG Therapy
Sponsor:
Ractigen Therapeutics
Organization:
Ractigen Therapeutics
Study Overview
Official Title:
A Phase Ⅰ Open Label Multi-center Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Efficacy of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer NMIBC Who Have Failed Bacillus Calmette Guérin BCG Therapy
Status:
RECRUITING
Status Verified Date:
2024-06
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 is an open label multi-center study to evaluate the safety tolerability pharmacokinetics pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy
Detailed Description:
The study is planned to include a 33 dose escalation phase The primary study period includes a screening period a treatment and Dose-Limiting Toxicity DLT assessment period and a follow-up period
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