This is an open-label, single arm , Ib/II phase trial to evaluate the efficacy and safety of AK112(ivonescimab)monotherapy as first-line treatment for favourable risk advanced/metastatic renal cell carcinoma (a/m RCC). Subjects will receive AK112 until disease progression, unacceptable toxic effects, death,a decision by the physician or patient to withdraw from the trial,or 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
A novel PD-1/VEGF bispecific antibody; RP2D intravenously (IV),Q3W
ORR per RECIST v1.1 assessed by investigators
ORR is the proportion of subjects with complete response(CR) and partial response(PR) , based on RECIST v1.1
Time frame: Up to 2 years
DCR per RECIST v1.1 as assessed by investigators
DCR is the proportion of subjects with complete response(CR), partial response(PR) and stable disease (SD) based on RECIST v1.1
Time frame: Up to 2 years
Duration of response (DOR)
Duration of response (DOR) assessed according to RECIST v1.1
Time frame: Up to 2 years
Progression-free survival (PFS)
PFS is defined as the time from the the start of treatment till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
Time frame: 3 years
Overall survival (OS)
OS is the time from the first use of a therapeutic drug to death from any cause
Time frame: 4 years
Treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, also types and degree
Time frame: 3 years
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