Viewing Study NCT05808608



Ignite Creation Date: 2024-05-06 @ 6:50 PM
Last Modification Date: 2024-10-26 @ 2:56 PM
Study NCT ID: NCT05808608
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-09-25
First Post: 2023-03-23

Brief Title: A Study of AK104 Plus Axitinib in AdvancedMetastatic Special Pathological Subtypes of Renal Cell Carcinoma
Sponsor: Hao Zeng
Organization: West China Hospital

Study Overview

Official Title: A Study of AK104 Plus Axitinib in AdvancedMetastatic Special Pathological Subtypes of Renal Cell Carcinoma
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-09
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 Phase IbII open-label single arm trial to evaluate the efficacy and safety of AK104 in combination with axitinib as a first-line treatment for advancedmetastatic special pathological subtypes of renal cell carcinoma ssRCC Subjects will receive AK104 plus axitinib until disease progression development of unacceptable toxic effects death a decision by the physician or patient to withdraw from the trial The primary endpoint is ORR and PFS per RECIST v11 and imRECIST as assessed by investigators
Detailed Description: None

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