RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT07538804Sponsor: Avistone Biotechnology Co., Ltd.Last updated: 2026-05-22

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.

Arms & interventions

DrugANS02
4 dose levels would be explored during the study.

Outcome measures

Primary

Incidence of Adverse Events (AEs)
Number of patients with adverse events by system organ class and preferred term
Time frame: From the time of first dose to 28 days post last dose of ANS02
Incidence of Serious Adverse Events (SAEs)
Number of patients with serious adverse events by system organ class and preferred term
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
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study 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
Measured by laboratory and vital sign variables over time including change from baseline
Time frame: From time of first dose to 28 days post last dose of ANS02

Secondary

Pharmacokinetics of ANS02: Plasma PK concentrations
Time frame: From date of first dose of ANS02 up until 7 days post last dose
Pharmacokinetics of ANS02: Area under the concentration time curve (AUC)
Time frame: From date of first dose of ANS2 up until 7 days post last dose
Pharmacokinetics of ANS02: Maximum plasma concentration of the study drug (C-max)
Time frame: From date of first dose up until 7 days post last dose
Pharmacokinetics of ANS02: Time to maximum plasma concentration of the study drug (T-max)
Time frame: From date of first dose up until 7 days post last dose
Pharmacokinetics of ANS02: Clearance
Time frame: From date of first dose up until 7 days post last dose
Pharmacokinetics of ANS02: Half-life
Time frame: From date of first dose up until 7 days post last dose
Proportion of patients with radiological response (ORR)
Time frame: From date of first dose of ANS02 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)
Duration of Response (DoR)
Time frame: From date of first dose of ANS02 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Disease Control Rate (DCR)
Time frame: From date of first dose of ANS02 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Progression free Survival (PFS)
Time frame: From date of first dose of ANS02 up until date of progression or death due to any cause (approximately 2 years)]
Overall Survival (OS)
Time frame: From date of first dose of ANS02 up until the date of death due to any cause (approximately 2 years)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 locations (1)

Research Site

Fairfax, Virginia, 22031

Recruiting