Study Design and Patients
Tumors
TUMORS, SOLID TUMORS
This phase I, open-label, multicenter, dose-escalation, and dose-expansion study was conducted at three national clinical institutions in China. Patients aged 18-75 years with histologically or cytologically confirmed advanced solid tumors who had failed at least one line of prior systemic treatment were enrolled. At baseline, all patients enrolled in the dose-escalation phase had to have at least one evaluable lesion, and those in the dose-expansion period had to have at least one measurable lesion, according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).Dose escalation was conducted using a modified Fibonacci 3 + 3 method (The dose-expansion period included 3 populations: dose groups in which at least one patient achieved complete response (CR) or partial response (PR) per RECIST v1.1This trial was conducted in accordance with the ethical principles for medical research involving human subjects stated in the Declaration of Helsinki, the ethical requirements of the Chinese Good Clinical Practice guidelines, and the Technical Guidelines for Clinical Trials of Antineoplastic Drugs issued by the National Medical Products Administration. All patients provided written informed consent to participate. The trial is registered with ClinicalTrials.gov (NCT03508011).