Ignite Creation Date:
2024-07-17 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06472895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
A Study of AK112 Monotherapy in AdvancedMetastatic Renal Cell Carcinoma
Sponsor:
Peking University Cancer Hospital Institute
Organization:
Peking University Cancer Hospital Institute
Study Overview
Official Title:
A Study of AK112 Monotherapy in AdvancedMetastatic Renal Cell Carcinoma
Status:
NOT_YET_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 single arm IbII phase trial to evaluate the efficacy and safety of AK112ivonescimabmonotherapy as first-line treatment for favourable risk advancedmetastatic renal cell carcinoma am RCC
Subjects will receive AK112 until disease progression unacceptable toxic effects deatha decision by the physician or patient to withdraw from the trialor AK112 exposure over 2 years
The study set dose exploration stage and dose expansion stage respectively Firstly include a few subjects for observation in dose exploration stage and select appropriate dose to enter expansion then continue to include more subjects to further assessment
Subjects will receive AK112 until disease progression unacceptable toxic effects deatha decision by the physician or patient to withdraw from the trialor AK112 exposure over 2 years
The study set dose exploration stage and dose expansion stage respectively Firstly include a few subjects for observation in dose exploration stage and select appropriate dose to enter expansion then continue to include more subjects to further assessment
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