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A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

A Study to Investigate ANS014004 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 Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors.

Eligibility

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 a pathogenetic MET alteration (including MET mutation, MET amplification, MET overexpression, MET fusion)

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

NCT06307795

Avistone Biotechnology Co., Ltd.

27 April 2025

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