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

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

Recruiting
18 years and older
All
Phase 1
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  • Simplified (AI rewritten)

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Overview

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.

Eligibility

Inclusion Criteria:

  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2
  • Life expectancy ≥ 12 weeks
  • Measurable disease per RECIST v1.1
  • Adequate organ and marrow function as defined in the protocol
  • With documentation of ROS1 or NTRK 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 details
    Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration

NCT06716138

Avistone Biotechnology Co., Ltd.

14 May 2026

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