This is open-label, multicenter, Phase I/II study is designed to evaluate the Safety and tolerability and Efficacy of IBI334 Monotherapy in participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
There are six dose of IBI334 ,QW IV in first cycle and Q2W IV behind the first cycle
Affiliated Cancer Hospital of Shandong First Medical university
Jinan, Shandong, China
Number of patients with treatment-related adverse events
Time frame: Up to 60 days post last dose
Percentage of subjects woth Dose-Limitine toxicities(DLTs)
Time frame: Up to 28 days following first dose
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: area under the curve (AUC)
Time frame: Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to:maximum concentration (Cmax)
Time frame: Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: clearance (CL)
Time frame: Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: apparent volume of distribution (V)
Time frame: Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: half-life (t1/2).
Time frame: Day 1 up to treatment duration reaches 24 months
Prevalence and incidence of anti-IBI334 antibodies.
Time frame: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy : objective response rate (ORR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
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Time frame: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy : duration of response (DoR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Time frame: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy : disease control rate (DCR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Time frame: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy :time to response (TTR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Time frame: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy :progression-free survival (PFS) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Time frame: Day 1 up to treatment duration reaches 24 months
Preliminary efficacy :overall survival (OS)
Time frame: Day 1 up to treatment duration reaches 24 months