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

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

Recruiting
18 years and older
All
Phase 1/2
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Overview

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

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

Study details
    Non-Small Cell Lung Cancer

NCT07538804

Avistone Biotechnology Co., Ltd.

27 June 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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