A phase Ia study to evaluate the safety, tolerance, pharmacokinetics and preliminary efficacy of IBI345 in patients with CLDN18.2 positive solid tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
IBI345 CAR-T cell injection by intravenous infusion
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: up to 2 years
Objective Response Rate (ORR) according to RECIST version 1.1
Defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥4 weeks after initial documentation of response.
Time frame: up to 2 years
Duration of Response (DOR) according to RECIST version 1.1
Defined as time from date of first objective response (either CR or PR) to first documentation of radiographic disease progression or death due to any cause, whichever occurs first.
Time frame: up to 2 years
Disease Control Rate (DCR) according to RECIST version 1.1
Defined as the proportion of subjects who have achieved CR, PR, or stable disease (duration of stable disease should be ≥3 months).
Time frame: up to 2 years
Time to Response (TTR) according to RECIST version 1.1
Defined as the time from first dose to first documentation of objective response (either CR or PR).
Time frame: up to 2 years
Progression-Free Survival (PFS) according to RECIST version 1.1
Defined as the time from first dose to first documentation of radiographic disease progression or death due to any cause, whichever occurs first.
Time frame: up to 2 years
Overall Survival (OS) according to RECIST version 1.1
Defined as the time from first dose to the date of death due to any cause.
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Time frame: up to 2 years
Peak Plasma Concentration (Cmax)
Time frame: up to 1 years
Area under theplasma concentration versus time curve (AUC)
Time frame: up to 1 years
Time of maximum drug concentration in hours [Tmax]
Time frame: up to 1 years
Elimination half-life in hours [t1/2]
Time frame: up to 1 years
Clearance (CL)
Time frame: up to 1 years
Distribution Volume (Vd)
Time frame: up to 1 years
Number of Participants With anti-drug antibody (ADA)
Time frame: up to 1 years
Number of Participants With Neutralizing Antibodies (NAbs)
Time frame: up to 1 years