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

May 20, 2026 updated by: Avistone Biotechnology Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

294

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Research Site
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Not yet recruiting
        • Research Site
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Research Site
  • United States
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ANS02
ANS02 capsules, oral administration
Drug: ANS02
4 dose levels would be explored during the study.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of ANS02: Plasma PK concentrations
Time Frame: From date of first dose of ANS02 up until 7 days post last dose
Measurement of plasma concentrations of ANS02
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
Measurement of PK parameters: Area under the concentration time curve (AUC)
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
Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)
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
Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)
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
Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance)
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
Measurement of PK parameters: Terminal elimination half-life (t 1/2)
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)
Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1
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)
The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression
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)
The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1)
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)]
The time from first dose until RECIST 1.1 defined disease progression or death due to any cause
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)
The time from the date of the first dose of study treatment until death due to any cause
From date of first dose of ANS02 up until the date of death due to any cause (approximately 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avistone Biotechnology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 9, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

October 30, 2029

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANS02-I/II-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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