A Study to Investigate ANS02 in Participants With EGFR Mutation-Positive Non-Small Cell Lung Cancer
Recruiting · NCT07538804 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
ANS02
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
5 locations listed across 1 US state.
- Research Site - Fairfax, Virginia, United States
- Research Site - Guangzhou, Guangdong, China
- Research Site - Harbin, Heilongjiang, China
- Research Site - Zhengzhou, Henan, China
- Study Site - Chengdu, Sichuan, China