Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06186414
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2023-12-07
Brief Title:
A Study to Investigate the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of SIM0237 Alone or in Combination With BCG in NMIBC
Sponsor:
Jiangsu Simcere Pharmaceutical Co Ltd
Organization:
Jiangsu Simcere Pharmaceutical Co Ltd
Study Overview
Official Title:
An Open-Label Multicenter Phase 1 Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of SIM0237 Alone or in Combination With BCG in Non-Muscle-Invasive Bladder Cancer
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 multicenter phase 1 study to evaluate the safety efficacy and pharmacokinetics PK characteristics of SIM0237 alone or in combination with bacillus Calmette-Guerin BCG in participants with Non-Muscle-Invasive Bladder Cancer NMIBC
Detailed Description:
The study starts with a dose escalation part followed by a dose expansion part The primary objective of the dose escalation part is to evaluate the safety and tolerability of SIM0237 alone or in combination with BCG and determine the recommended doses RD The primary objective of the dose expansion part is to evaluate the preliminary efficacy of SIM0237 alone or in combination with BCG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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