Recruiting
Phase 1
Phase 2

ANS02

Sponsor:

Avistone Biotechnology Co., Ltd.

Code:

NCT07538804

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ANS02

Study Details

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT07538804

Start date

Jul 10, 2026

Status verified date

May, 2026

Completion date

Oct 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

294 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ANS02

ANS02 capsules, oral administration

Interventions

ANS02

4 dose levels would be explored during the study.

Primary outcome measure

  • Incidence of Adverse Events (AEs) [ Time Frame: From the time of first dose to 28 days post last dose of ANS02 ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: From time of first dose to 28 days post last dose of ANS02 ]
  • Incidence of dose-limiting toxicities (DLT) as defined in the protocol [ Time Frame: From time of first dose of ANS02 to end of DLT period (approximately 28 days) ]
  • Incidence of baseline laboratory finding, ECG and vital signs changes [ Time Frame: From time of first dose to 28 days post last dose of ANS02 ]

Central Contacts and Locations

Central contacts

Avistone Clinical Study Information Center

8610 84148921information.center@avistonebio.com

Locations

Research Site

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Avistone Biotechnology Co., Ltd.

Last update posted

Jul 6, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Avistone Biotechnology Co., Ltd. on 2026-07-06.