NCT07310134

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

An Open-Label, Multicenter Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Dose Escalation and Dose Expansion of ZX-8177 Tablets in Chinese Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Nanjing Zenshine Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Dose Escalation Phase: The specific design is as follows: The starting dose is 100 mg BID, with a total of five predefined dose groups (100 mg BID, 200 mg BID, 400 mg BID, 800 mg BID, and 1200 mg BID). The trial employs an accelerated titration combined with a "3+3" dose escalation design: For the first two dose groups (100 mg BID and 200 mg BID), one subject each will initially be enrolled for accelerated titration and dose escalation. If the enrolled subject in either group does not experience a Grade 2 or higher non-disease-related toxicity event (excluding asymptomatic laboratory abnormalities judged by the investigator to require no intervention) from the first dose administration until the end of the first cycle (the DLT observation period), the trial for the next dose group will proceed. If a DLT occurs, the escalation method will switch to the "3+3" dose escalation approach. Starting from the 400 mg BID dose group, three subjects will initially be enrolled in each dose group. If no DLT is observed in the three subjects of a given dose group during the DLT observation period, the clinical trial for the next predefined escalated dose group will proceed. If one of the three subjects in a dose group experiences a DLT during the DLT observation period, an additional three subjects will be enrolled in that dose group. If no DLT is observed among the newly enrolled three subjects, three subjects may be enrolled for the next higher dose group. If one or more DLTs are observed among the newly enrolled three subjects, that dose group is defined as the DLT dose group. No additional subjects may be enrolled in this group, and the dose escalation phase will conclude. The previous dose will then be determined as the Maximum Tolerated Dose (MTD). Enrollment in the DLT dose group must not exceed six subjects.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	ZX-8177	Dose Escalation Phase: The starting dose is 100 mg BID, with a total of 5 predefined dose groups (100 mg BID, 200 mg BID, 400 mg BID, 800 mg BID, and 1200 mg BID).

Timeline

• Start date: 2025-12-26
• Primary completion: 2026-11-30
• Completion: 2026-12-30
• First posted: 2025-12-30
• Last updated: 2026-01-02

Locations

1 site across 1 country: China