Advanced Solid Tumor Clinical Trial
Official title:
A Dose-Escalation and Expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ZX-101A Monotherapy in Patients With Advanced Solid Tumors
ZX-101A-201 is a phase I, open-label, multicenter study which includes dose escalation and dose expansion of ZX-101A. It is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and antitumor activity of ZX-101A in patients with advanced solid tumors.
Phase I includes two parts: dose escalation and dose expansion. - Part 1. ZX-101A dose escalation: 1) To evaluate the safety and tolerability of ZX-101A in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD) or optimal biological administration dose (OBD), and the recommended phase II dose clinical studies (RP2D); 2) To evaluate the pharmacokinetic (PK) characteristics of ZX-101A in patients with advanced solid tumors; 3) To evaluate the antitumor activity of ZX-101A in patients with advanced solid tumors, and provide dose basis for subsequent clinical trials; 4) To explore the pharmacodynamic (PD) characteristics of ZX-101A in patients with advanced solid tumors. - Part 2. ZX-101A dose expansion: 1) To evaluate the safety and tolerability of ZX-101A in patients with advanced solid tumors; 2) To evaluate the PK profile of ZX-101A in patients with advanced solid tumors; 3) To evaluate the antitumor activity of ZX-101A in patients with advanced solid tumors, and provide dose basis for subsequent clinical trials; 4) To explore the PD characteristics of ZX-101A in patients with advanced solid tumors; 5) To explore the effect of ZX-101A on immune cytokines in serum. ;
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