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

Sponsor: Avistone Biotechnology Co., Ltd.

Sponsor score: 0

ClinicalTrials ID:NCT07538804

This Phase I/II study assesses ANS02's safety, tolerability, and preliminary efficacy in advanced NSCLC patients. Eligible participants are adults with ECOG 0-1, a life expectancy of at least 12 weeks, measurable disease, adequate organ function, and documented EGFR alterations. The study explores four dose levels of ANS02 as monotherapy.

Patient Parameters

Program 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 Criteria

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

Locations

FACILITYZIPCITYSTATE
Research Site22031FairfaxVirginia

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