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
The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.
Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
Histologically and/or cytologically confirmed locally advanced unresectable or metastatic malignant solid tumors.
The interval between the end of the last systemic anti-tumor treatment and the first dose should be at least 3 weeks.
There is active or untreated brain metastases,Meningeal metastases, spinal cord compression, or leptomeningeal disease.
Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1/month).
Patients who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.
gastrointestinal perforation or gastrointestinal fistula within 6 months before the first dose.
Single group
AK132
DrugIV infusion, specified dose on specified days.
dose-limiting toxicity （DLT）、adverse event（AE）、serious adverse event（SAE）
incidence and severity of DLT, adverse events (AE), serious adverse events (SAE)
Maximum tolerated dose (MTD),RP2D
Maximum tolerated dose (MTD), Recommended dose for phase II trial
Pharmacokinetic
The PK parameters include serum concentrations of AK132 at different timepoints after AK132 administration.
Immunogenicity assessmen
The immunogenicity of AK132 will be assessed by summarizing the number and percentage of subjects who develop detectable antidrug antibodies (ADAs).
Objective response rate (ORR)
ORR is the proportion of subjects with CR or PR based on RECIST v1.1
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.
This trial is not recruiting at the moment. You can still explore other options:
