NCT07538804

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.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for phase_1 nonsmall-cell-lung-cancer

Timeline
41mo left

Started Jun 2026

Geographic Reach
2 countries

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 9, 2026

Expected
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2029

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

April 13, 2026

Last Update Submit

April 13, 2026

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

  • Incidence of Adverse Events (AEs)

    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)

    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

    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

    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 Outcomes (11)

  • Pharmacokinetics of ANS02: Plasma PK concentrations

    From date of first dose of ANS02 up until 7 days post last dose

  • Pharmacokinetics of ANS02: 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)

    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)

    From date of first dose up until 7 days post last dose

  • Pharmacokinetics of ANS02: Clearance

    From date of first dose up until 7 days post last dose

  • +6 more secondary outcomes

Study Arms (1)

ANS02

EXPERIMENTAL
Drug: ANS02

Interventions

ANS02DRUG

ANS02 is a novel, non-covalent, mutant-selective macrocyclic, brain-penetrant, oral EGFR TKI.

ANS02

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Fairfax, Virginia, 22031, United States

Location

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Harbin, Heilongjiang, China

Location

Research Site

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Avistone Clinical Study Information Center

CONTACT

8610 84148921information.center@avistonebio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start (Estimated)

June 9, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

October 30, 2029

Last Updated

April 20, 2026

Record last verified: 2026-04

Locations

CN(3)US(1)