The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of SHR-4685 in participants with advanced solid tumors.
Have fully understood this study and voluntarily signed the informed consent form, with good compliance and cooperation with follow-up;
Age 18-75 years, any gender;
Performance status ECOG score 0 or 1;
Expected survival time greater than 3 months;
Participants who have received any approved anti-tumor drugs (including investigational anti-tumor drugs) within 4 weeks prior to the first dose of the IP;
Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 or to the level specified in the inclusion/exclusion criteria;
Presence of central nervous system (CNS) metastases;
Concurrent active malignancy other than the primary tumor;
Single group
SHR-4685
DrugSHR-4685, in different doses.
Dose-limiting toxicity (DLT) of SHR-4685.
Maximum tolerated dose (MTD) of SHR-4685.
Recommended Phase II Dose (RP2D) of SHR-4685.
Adverse events (AEs).
The concentration of SHR-4685 in plasma will be determined.
Cmax will be derived.
Time to maximum concentration (Tmax).
Evaluation of pharmacokinetic parameter of SHR-4685.
Area under the concentration-time curve from time 0 to time t (time of the last measurable concentration) (AUC0-t).
Evaluation of pharmacokinetic parameter of SHR-4685. The concentration of SHR-4685 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.
The concentration of Anti-SHR-4685 antibodies (ADA) in plasma will be determined.
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