Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ZX-8177 in Patients With Advanced Solid Tumors

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).

Timeline

Start

2025-12-26

Primary completion

2026-11-30

Completion

2026-12-30

Drugs

Indications