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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAvistone Biotechnology Co., Ltd.

About this trial

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

Qualifiers

Age ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1

Life expectancy ≥ 12 weeks

Measurable disease per RECIST v1.1

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ANS02

Treatment groups

294 Participants
are divided into 1 treatment group