This is A Phase I Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Preliminary Antineoplastic Activity of The anti-CLDN18.2 and CD47 Bispecific Antibody AK132 in Advanced Malignant Solid Tumor
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
IV infusion, specified dose on specified days.
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center, Guangzhou, China
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
dose-limiting toxicity (DLT)、adverse event(AE)、serious adverse event(SAE)
incidence and severity of DLT, adverse events (AE), serious adverse events (SAE)
Time frame: Up to 2 years
Maximum tolerated dose (MTD),RP2D
Maximum tolerated dose (MTD), Recommended dose for phase II trial
Time frame: Up to 2 years
Pharmacokinetic
The PK parameters include serum concentrations of AK132 at different timepoints after AK132 administration.
Time frame: Up to 2 years
Immunogenicity assessmen
The immunogenicity of AK132 will be assessed by summarizing the number and percentage of subjects who develop detectable antidrug antibodies (ADAs).
Time frame: Up to 2 years
Objective response rate (ORR)
ORR is the proportion of subjects with CR or PR based on RECIST v1.1
Time frame: Up to 2 years
Duration of response (DoR)
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST Version 1.1).
Time frame: Up to 2 years
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Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Hunan Provincial Cancer Hospital
Changsha, Hunan, China
Time to response (TTR)
Time to response (TTR) is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR (based on RECIST Version 1.1).
Time frame: Up to 2 years
Progression-free survival (PFS)
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).
Time frame: Up to 2 years
Overall survival (OS)
OS defined as the time from the first dose to death from any cause.
Time frame: Up to 2 years