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

Recruiting now · Phase 1

Conditions studied: Locally Advanced or Metastatic Solid Tumors

In brief

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.

Key facts

Study ID

NCT06307795

Run by

Avistone Biotechnology Co., Ltd.

People needed

63

Starts

2024-06-24

Expected to finish

2027-10-01

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Diego — San Diego, California, United States (enrolling)
• Sarah Cannon Research Institute — Denver, Colorado, United States (enrolling)
• Advent Health — Orlando, Florida, United States (enrolling)
• Henry Ford Health Cancer — Detroit, Michigan, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• The University of Texas - MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• NEXT Oncology, Virginia — Fairfax, Virginia, United States (enrolling)
• Swedish Cancer Institute — Seattle, Washington, United States (enrolling)
• BC Cancer Vancouver Centre — Vancouver, British Columbia, Canada (enrolling)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• Beijing Chest Hospital — Beijing, Beijing Municipality, China
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
• Henan Cancer Hospital — Zhengzhou, Henan, China
• Shandong Cancer Hospital — Jinan, Shandong, China
• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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