Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181266
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2023-12-12
Brief Title:
A Phase 11b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer
Sponsor:
Prokarium Ltd
Organization:
Prokarium Ltd
Study Overview
Official Title:
A Phase 11b Study Evaluating the Safety Pharmacology and Clinical Effect of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer
Status:
RECRUITING
Status Verified Date:
2023-11
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:
PARADIGM-1
Brief Summary:
This is a first-in-human multicenter Phase 11b 3-part double-blind study of ZH9 in patients with recurrent NMIBC who are eligible for intravesical therapy In Part 1 the safety tolerability and pharmacology of ZH9 IVI will be evaluated in a single ascending dose SAD patient cohort In Part 2 the safety tolerability and pharmacology of ZH9 oral prime followed by ZH9 IVI will be evaluated in 2 patient cohorts at the doses and schedule established in Part 1 In Part 3 the safety pharmacology and clinical efficacy of ZH9 will be further evaluated in 2 expansion cohorts of patients with recurrent intermediate- and high-risk NMIBC
Detailed Description:
None
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