Investigating ANS014004 for advanced 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
PHASE1 · Avistone Biotechnology Co., Ltd. · NCT06307795
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 | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Avistone Biotechnology Co., Ltd. (industry) |
| Locations | 15 sites (San Diego, California and 14 other locations) |
| Trial ID | NCT06307795 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with locally advanced or metastatic solid tumors and specific MET alterations.
Not a fit: Patients with active infections, untreated CNS metastases, or serious cardiovascular diseases may not benefit from this study.
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 performed: Other studies targeting MET alterations have shown promise, suggesting potential for success with this approach.
Eligibility criteria
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 this trial is running
San Diego, California and 14 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Locally Advanced or Metastatic Solid Tumors, ROS1, NTRK, ROS1/NTRK