This study is an open-label, multicenter, dose-escalation and dose-expansion Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of AK150 in patients with advanced malignant solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
96
IV infusion, administered on Day 1 of each cycle, Q2W,continuous treatment
Fujian Cancer Hospital
Fuzhou, Fujian, China
Dongguan People's Hospital
Dongguan, Guangdong, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Number of participants with a Dose Limiting Toxicity (DLT)
DLTs will be assessed during the first 4 weeks of treatment for dose-escalation I phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 2 cycles (4 weeks) of treatment
Time frame: During the first 4 weeks
Number of participants with adverse events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment
Time frame: From the participant signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first.
Serum PK concentration of AK150
Serum PK of AK150 at different timepoints after AK150 administration
Time frame: From pre-dose to the end of the last dose, an average of 6 months.
The immunogenicity of AK150
The immunogenicity of AK150 will be assessed by summarizing the number of participants who develop detectable anti-drug antibodies (ADAs)
Time frame: From pre-dose to 30 days post end of treatment
Overall response rate (ORR)
Efficacy measures such as ORR, which is the proportion of participants with CR or PR by investigator based on RECIST v1.1
Time frame: Up to 12 year.
Progression-Free Survival(PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by investigator Per RECIST 1.1.
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Time frame: Up to 1 year
Disease control rate(DCR)
DCR, which is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1.
Time frame: Up to 1 year.