Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT07087158
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma
Sponsor:
Imbioray (Hangzhou) Biomedicine Co., Ltd.
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Open-Label, Active-Controlled Phase II Study Evaluating the Efficacy and Safety of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
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 a multicenter, randomized, open-label, active-controlled Phase II clinical study evaluating the efficacy and safety of IBR854 combined with Pazopanib versus Pazopanib in Advanced Renal Cell Carcinoma.
Detailed Description:
This is a multicenter, randomized, open-label, active-controlled study. Eligible patients with Advanced Renal Cell Carcinoma who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned in a 2:1 ratio to either the experimental arm or the control arm.
* Experimental arm: IBR854 in combination with Pazopanib
* Control arm: Pazopanib The primary endpoint is PFS per RECIST 1.1. Efficacy and safety datas will be continuously collected until criteria for discontinuation are met.
* Experimental arm: IBR854 in combination with Pazopanib
* Control arm: Pazopanib The primary endpoint is PFS per RECIST 1.1. Efficacy and safety datas will be continuously collected until criteria for discontinuation are met.
Study Oversight
Has Oversight DMC:
False
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?: