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A Study to Investigate ANS02 in Participants With EGFR Mutation-Positive Non-Small Cell Lung Cancer
Sponsor: Avistone Biotechnology Co., Ltd.
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.
Official title: A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS02 in Participants With EGFR Mutation-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
294
Start Date
2026-06-09
Completion Date
2029-10-30
Last Updated
2026-04-20
Healthy Volunteers
No
Conditions
Interventions
ANS02
ANS02 is a novel, non-covalent, mutant-selective macrocyclic, brain-penetrant, oral EGFR TKI.
Locations (4)
Research Site
Fairfax, Virginia, United States
Research Site
Guangzhou, Guangdong, China
Research Site
Harbin, Heilongjiang, China
Research Site
Zhengzhou, Henan, China