Investigating ANS014004 for advanced solid tumors
Official title: 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
Run by Avistone Biotechnology Co., Ltd. · NCT06307795 · Data updated 2026-11-12
This study is testing a new drug called ANS014004 to see if it is safe and effective for adults with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 63 (estimated) |
| Sponsor | Avistone Biotechnology Co., Ltd. Industry-sponsored |
| Locations | 15 sites (San Diego, California and 14 other locations) |
| Status | Recruiting |
| Started | June 24, 2024 |
| Main results expected | April 2027 |
| Study ends | October 2027 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT06307795 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with locally advanced or metastatic solid tumors and specific MET alterations.
✕Probably not a fit
Patients with active infections, untreated CNS metastases, or serious cardiovascular diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1, first-in-human, open-label, multi-center study aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of ANS014004 in participants with locally advanced or metastatic solid tumors. The study will enroll adult patients who meet specific eligibility criteria, including having measurable disease and a pathogenetic MET alteration. Participants will receive ANS014004 as a single agent to assess its potential effectiveness and safety profile.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.
How similar studies have gone: Other studies targeting MET alterations have shown promise, suggesting potential for success with this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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University of California, San Diego
San Diego, California, United States Recruiting -
Sarah Cannon Research Institute
Denver, Colorado, United States Recruiting -
Advent Health
Orlando, Florida, United States Recruiting -
Henry Ford Health Cancer
Detroit, Michigan, United States Recruiting -
NYU Langone Health
New York, New York, United States Recruiting -
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States Recruiting
Show 9 more locations
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NEXT Oncology, Virginia
Fairfax, Virginia, United States Recruiting -
Swedish Cancer Institute
Seattle, Washington, United States Recruiting -
BC Cancer Vancouver Centre
Vancouver, British Columbia, Canada Recruiting -
Princess Margaret Cancer Centre
Toronto, Ontario, Canada Recruiting -
Beijing Chest Hospital
Beijing, Beijing Municipality, China Not yet recruiting -
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China Not yet recruiting -
Henan Cancer Hospital
Zhengzhou, Henan, China Not yet recruiting -
Shandong Cancer Hospital
Jinan, Shandong, China Not yet recruiting -
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China Not yet recruiting
Study contacts
- Study coordinator: Avistone Clinical Study Information Center
- Email: information.center@avistonebio.com
- Phone: 8610 84148921
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.