Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ZX-8177 in Patients With Advanced Solid Tumors
Trial Parameters
Brief Summary
This study is an open-label, multicenter, phase I clinical trial involving dose escalation and dose expansion of ZX-8177 in patients with advanced unresectable, recurrent, or metastatic solid tumors. The study consists of two stages: dose escalation and dose expansion. It primarily aims to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), biomarkers, and preliminary efficacy of ZX-8177 as a monotherapy with continuous administration in Chinese patients with advanced solid tumors who have failed standard treatment or lack standard treatment options. The study also seeks to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD)/optimal biological dose (OBD), or recommended phase II dose (RP2D).
Eligibility Criteria
Inclusion Criteria: * 1\. Voluntarily participate in this clinical trial, understand and comply with the study procedures, and voluntarily sign the Informed Consent Form (ICF). * 2\. No gender restriction, age ≥ 18 years at the time of signing ICF. * 3\. Minimum expected survival period ≥ 3 months (as determined by the investigator's assessment). * 4\. ECOG score is 0-1. * 5\. Advanced malignant tumors confirmed by histology/cytology: Advanced solid tumors without standard effective treatment options, or those that are ineffective or recurrent after standard treatment, or intolerant to standard treatment, or for which standard treatment is not applicable at this stage. * 6\. The subject must have at least one measurable lesion defined by RECIST v1.1, which has not been previously irradiated or has shown clear disease progression after radiotherapy. * 7.Adequate Organ Function: 1. Renal: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min \[Cockcroft-Gault formula: (\[140 -