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

NCT07310134 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-02

No results posted yet for this study

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).

Conditions

Interventions

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).

Sponsors & Collaborators

  • Nanjing Zenshine Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-26
Primary Completion
2026-11-30
Completion
2026-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07310134 on ClinicalTrials.gov