ANS02 in EGFR-mutant NSCLC (early-phase study)
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
Run by Avistone Biotechnology Co., Ltd. · NCT07538804 · Data updated 2026-11-12
This first-in-human study tests ANS02 in adults with advanced EGFR-mutant non-small cell lung cancer to see if it is safe, tolerable, and shows any tumor activity.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 294 (estimated) |
| Sponsor | Avistone Biotechnology Co., Ltd. Industry-sponsored |
| Locations | 5 sites (Fairfax, Virginia and 4 other locations) |
| Status | Recruiting |
| Started | July 10, 2026 |
| Main results expected | June 30, 2029 |
| Study ends | October 30, 2029 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07538804 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with EGFR-altered advanced NSCLC and good performance status (ECOG 0–1) who have measurable disease and adequate organ function.
✕Probably not a fit
Patients with active infections, CNS metastases requiring treatment, or significant cardiovascular/cerebrovascular disease may not benefit or could be at higher risk.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multi-center, open-label Phase I/II trial of ANS02 given as monotherapy in adults with advanced NSCLC and EGFR alterations. The study aims to characterize safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity, along with early signals of efficacy. It plans to enroll patients with measurable disease, adequate organ function, and good performance status, across sites in the US and China. The trial includes dose exploration in Phase I followed by expansion in Phase II to assess preliminary efficacy. Results will guide future development of ANS02 in this patient population.
Why it matters
Potential benefit: If successful, participants may experience tumor control or slowing of disease with ANS02.
How similar studies have gone: Early-phase studies of EGFR-targeted or novel agents in NSCLC have shown variable signals; this represents a novel first-in-human approach for ANS02.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Research Site
Fairfax, Virginia, United States Recruiting -
Research Site
Harbin, Heilongjiang, China Recruiting -
Research Site
Guangzhou, Guangdong, China Not yet recruiting -
Research Site
Zhengzhou, Henan, China Not yet recruiting -
Study Site
Chengdu, Sichuan, China Not yet recruiting
Study contacts
- Study coordinator: Avistone Clinical Study Information Center
- Email: information.center@avistonebio.com
- Phone: 8610 84148921
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.