This is a Phase I clinical trial testing the safety and effectiveness of AK138D1in patients with advanced cancer. The study will enroll up to 200 patients with various types of advanced solid tumors who haven't responded to standard treatments. Patients will receive AK138D1 to determine the safest dose and evaluate if the drug can help treat their cancer.
This open-label, dose-escalation and expansion Phase I clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of AK138D1 in subjects with advanced malignant tumors. The study will test different doses of AK138D1 to find the recommended dose for future studies and assess whether the drug shows signs of effectiveness against cancer. Participants will receive AK138D1 through intravenous infusion and will be closely monitored for side effects and treatment response. The final number of participants enrolled will depend on the safety and effectiveness results observed during the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGAdverse events (AEs)
Incidence and severity of participants with adverse events
Time frame: Up to approximately 2 years
Dose-Limiting Toxicity (DLT)
Occurrence of DLTs and determination fo maximum tolerated dose (MTD)
Time frame: Up to approximately 2 years
Peak Plasma Concentration (Cmax) of AK138D1
AK138D1 serum drug concentrations in subjects at different time points after administration.
Time frame: Up to approximately 2 years
Area under the plasma concentration versus time curve (AUC) of AK138D1
The definite integral of the concentration of AK138D1 in blood plasma as a function of time.
Time frame: Up to approximately 2 years
Anti-drug antibodies (ADA)
Number of subjects with detectable anti-drug antibodies (ADA).
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , assessed by investigators based on RECIST v1.1.
Time frame: Up to approximately 2 years
Disease Control Rate (DCR) assessed by investigator per RECIST v1.1
Disease control rate (DCR) assessed according to RECIST v1.1.
Time frame: Up to approximately 2 years
Duration of response (DoR) assessed by the investigator per RECIST v1.1
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Duration of response (DoR) assessed according to RECIST v1.1.
Time frame: Up to approximately 2 years
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1
PFS is defined as the time from randomization to the first documented disease progression (per RECIST v1.1 criteria) assessed by investigators or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Time to response (TTR) assessed by the investigator per RECIST v1.1
Time to response (TTR) is defined as the time to response based on RECIST v1.1.
Time frame: Up to approximately 2 years
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 2 years