This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-1681 for injection in patients with advanced solid tumors.
Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
Subjects with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
Have at least one measurable tumor lesion per RECIST v1.1;
ECOG performance score of 0-1;
Subjects with active central nervous system metastases or meningeal metastases;
History of serious cardiovascular and cerebrovascular diseases;
Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
Severe infection within 4 weeks prior to the first dose;
Single group
SHR-1681
DrugSHR-1681 for Injection will be administrated per dose level in which the patients are assigned.
Maximum tolerated dose (MTD)
Maximum administered dose (MAD)
Recommended Phase 2 dose (RP2D)
Incidence and severity of adverse events (AEs)
Time to maximum concentration (Tmax) of SHR-1681
Maximum concentration (Cmax) of SHR-1681
Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t) of SHR-1681
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) of SHR-1681
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