Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06716138

A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

Led by Avistone Biotechnology Co., Ltd. · Updated on 2026-03-13

96

Participants Needed

5

Research Sites

212 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a first-in-human Phase I, multi-center, open-label study of ANS03 in patients with advanced solid tumors. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS03 as monotherapy.

CONDITIONS

Official Title

A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
  • Life expectancy of at least 12 weeks
  • Measurable disease according to RECIST version 1.1
  • Adequate organ and bone marrow function as defined in the study protocol
  • Documented ROS1 or NTRK genetic alteration
Not Eligible

You will not qualify if you...

  • Active infection including tuberculosis, hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
  • Known active or untreated central nervous system (CNS) metastases
  • Carcinomatous meningitis, meningeal metastases, or spinal cord compression
  • Serious cardiovascular or cerebrovascular diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10022

Actively Recruiting

2

Research Site

Fuzhou, Fujian, China

Actively Recruiting

3

Research Site

Guangzhou, Guangdong, China

Actively Recruiting

4

Research Site

Shanghai, Shanghai Municipality, China

Actively Recruiting

5

Research Site

Chengdu, Sichuan, China

Actively Recruiting

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Research Team

A

Avistone Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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