Clinical trial Recruiting at 10 sites Phase 1 Interventional Ages 18 and up

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

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment63 (estimated)
SponsorAvistone Biotechnology Co., Ltd.
Industry-sponsored
Locations15 sites (San Diego, California and 14 other locations)
StatusRecruiting
StartedJune 24, 2024
Main results expectedApril 2027
Study endsOctober 2027
Registry record updatedApril 17, 2026
Trial IDNCT06307795 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • ASP388B given alone or with standard therapies in solid tumors

    This early study tests ASP388B, first given alone or with standard cancer treatments, to see if it is safe and to find workable dose levels for solid tumors.

    Recruiting at 4 sites Phase 1/2 Astellas Pharma Inc · Lake Success, New York and 3 other locations · NCT07730021

  • First-in-human test of EMB-15 in adults with advanced or metastatic solid tumors

    This early phase trial tests EMB-15 to see if it is safe and tolerable in adults whose solid tumors have progressed after standard care or have no standard therapy.

    Recruiting Phase 1 Shanghai EpimAb Biotherapeutics Co., Ltd. · Guangzhou, Guangdong · NCT07607054

  • BC3195 plus pembrolizumab in advanced solid tumors

    This trial tests whether adding BC3195 to pembrolizumab is safe and shows preliminary activity in adults with locally advanced or metastatic solid tumors.

    Recruiting Phase 1/2 Biocity Biopharmaceutics Co., Ltd. · Guangzhou, Guangdong · NCT07469774

  • YL202 for advanced non‑small cell lung, colorectal, cervical, and other solid tumors

    This trial will try YL202, an antibody‑drug conjugate that targets HER3, in adults with advanced non‑small cell lung, colorectal, cervical, or other metastatic solid tumors who have received one or two prior systemic treatments.

    Recruiting Phase 2 MediLink Therapeutics (Suzhou) Co., Ltd. · Changsha, Hunan · NCT07202364

  • MRG007 (ARR-217) treatment for advanced solid tumors

    This trial will test MRG007 (ARR-217), an antibody-drug conjugate that targets CDH17, in adults with unresectable locally advanced or metastatic solid tumors who have exhausted standard therapies.

    Recruiting at 21 sites Phase 1 ArriVent BioPharma, Inc. · Los Angeles, California and 20 other locations · NCT07066657

  • Evaluating XB010 for patients with solid tumors

    This study is testing a new drug called XB010, alone and with another medication, to see if it can help people with advanced solid tumors who have few other treatment options.

    Recruiting at 18 sites Phase 1 Exelixis · Irvine, California and 19 other locations · NCT06545331

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.