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NCT06307795PHASE1Recruiting

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

Avistone Biotechnology Co., Ltd.

Start Date

6/24/2024

Completion Date

10/1/2027

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 Criteria

Age Range: 18 years to No maximum

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 or ROS1 alteration or NTRK alternation 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

Interventions

DRUG

ANS014004

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Conditions

Locally Advanced or Metastatic Solid Tumors

Locations

University of California, San Diego

San Diego, California 92093

United States

Sarah Cannon Research Institute

Denver, Colorado 80218

United States

Advent Health

Orlando, Florida 32804

United States

Henry Ford Health Cancer

Detroit, Michigan 48202

United States

NYU Langone Health

New York, New York 10003

United States

The University of Texas - MD Anderson Cancer Center

Houston, Texas 77030

United States

NEXT Oncology, Virginia

Fairfax, Virginia 22031

United States

Swedish Cancer Institute

Seattle, Washington 98195

United States

BC Cancer Vancouver Centre

Vancouver, British Columbia

Canada

Princess Margaret Cancer Centre

Toronto, Ontario

Canada

Beijing Chest Hospital

Beijing, Beijing Municipality 101149

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150010

China

Henan Cancer Hospital

Zhengzhou, Henan 450008

China

Shandong Cancer Hospital

Jinan, Shandong 250117

China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality 200030

China