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Study of ANS02 for EGFR-Mutated Non-Small Cell Lung Cancer

This study is testing a new drug called ANS02 for people with non-small cell lung cancer that has a specific change in the EGFR gene (EGFR mutation-positive). It's a "first-in-human" study, meaning it's one of the first times ANS02 is being given to people. The main goals are to see how safe ANS02 is, what side effects it might cause, and if it shows any early signs of helping to shrink tumors. You would need to be at least 18 years old, have a good general health status, and have measurable cancer. The study plans to include about 294 participants, but its current recruitment status is unclear.

Study design
This is a Phase I/II, multi-center, open-label study, meaning both you and your doctors will know you are receiving ANS02. It plans to enroll about 294 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the first dose of ANS02 until 28 days after your last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07538804

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Avistone Biotechnology Co., Ltd.
~294 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:ANS02

At a glance

Recruiting sites
2 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events (AEs)
Measured over From the time of first dose to 28 days post last dose of ANS02
+3 more outcomes measured

Conditions

Non-Small Cell Lung Cancer

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Where it's being run

5 sites across 5 states
Virginia1
Guangdong1
Heilongjiang1
Henan1
Sichuan1

Who to contact

Avistone Clinical Study Information Center
[email protected]
8610 84148921
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of Adverse Events (AEs)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

  • Incidence of Serious Adverse Events (SAEs)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

  • Incidence of dose-limiting toxicities (DLT) as defined in the protocolFrom 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

  • Incidence of baseline laboratory finding, ECG and vital signs changesFrom 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