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

Purpose

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.

Condition

  • Non-Small Cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ANS02 		ANS02 capsules, oral administration
  • Drug: ANS02
    4 dose levels would be explored during the study.

Recruiting Locations

Research Site
Fairfax, Virginia 22031

More Details

Status
Recruiting
Sponsor
Avistone Biotechnology Co., Ltd.

Study Contact

Avistone Clinical Study Information Center
8610 84148921
information.center@avistonebio.com