RecruitingPhase 1NCT06307795

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

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS014004 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors


Sponsor

Avistone Biotechnology Co., Ltd.

Enrollment

63 participants

Start Date

Jun 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 or ROS1 alteration or NTRK alternation

Exclusion Criteria4

  • 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

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Interventions

DRUGANS014004

Varying doses of ANS014004


Locations(10)

University of California, San Diego

San Diego, California, United States

Sarah Cannon Research Institute

Denver, Colorado, United States

Advent Health

Orlando, Florida, United States

Henry Ford Health Cancer

Detroit, Michigan, United States

NYU Langone Health

New York, New York, United States

The University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology, Virginia

Fairfax, Virginia, United States

Swedish Cancer Institute

Seattle, Washington, United States

BC Cancer Vancouver Centre

Vancouver, British Columbia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06307795


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