NCT07538804PHASE1, PHASE2Recruiting

A Study to Investigate ANS02 in Participants With EGFR Mutation-Positive Non-Small Cell Lung Cancer

Avistone Biotechnology Co., Ltd.

Start Date

7/10/2026

Completion Date

10/30/2029

Summary

This is a first-in-human (FIH) Phase I/II, multi-center, open-label, study of ANS02, in patients with advanced NSCLC. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS02 as monotherapy.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1 * Life expectancy ≥ 12 weeks * Measurable disease per RECIST v1.1 * Adequate organ and marrow function as defined in the protocol * With documentation of EGFR alteration Exclusion Criteria: * Active infection including tuberculosis and HBV, HCV or HIV * Known active or untreated CNS metastases * Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression * Participants with serious cardiovascular or cerebrovascular diseases

Interventions

DRUG

ANS02

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Conditions

Non-Small Cell Lung Cancer

Locations

Research Site

Fairfax, Virginia 22031

United States

Research Site

Guangzhou, Guangdong

China

Research Site

Harbin, Heilongjiang

China

Research Site

Zhengzhou, Henan

China

Study Site

Chengdu, Sichuan

China