NCT05258266

A Study to Evaluate the Activity, Safety and Tolerability of ZX-101A in Advanced Solid Tumors

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Nanjing Zenshine Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	ZX-101A	Q.D., oral dosing

Timeline

• Start date: 2022-03-09
• Primary completion: 2023-06-30
• Completion: 2024-04-30
• First posted: 2022-02-28
• Last updated: 2022-03-14

Locations

1 site across 1 country: China