Investigating ANS03 for advanced solid tumors with specific genetic alterations
Official title: A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS03 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration
Run by Avistone Biotechnology Co., Ltd. · NCT06716138 · Data updated 2026-11-12
This study is testing a new treatment called ANS03 to see if it can help people with advanced solid tumors that have specific genetic changes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Avistone Biotechnology Co., Ltd. Industry-sponsored |
| Locations | 5 sites (New York, New York and 4 other locations) |
| Status | Recruiting |
| Started | March 6, 2025 |
| Main results expected | December 30, 2027 |
| Study ends | March 30, 2029 |
| Registry record updated | March 13, 2026 |
| Trial ID | NCT06716138 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with measurable locally advanced or metastatic solid tumors and documented ROS1 or NTRK alterations.
✕Probably not a fit
Patients with active infections, untreated CNS metastases, or serious cardiovascular conditions 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 I, multi-center, open-label study evaluates the safety and tolerability of ANS03 in patients with locally advanced or metastatic solid tumors that have ROS1 or NTRK alterations. The study aims to assess the preliminary efficacy and anti-tumor activity of ANS03 as a monotherapy. Participants will be monitored for pharmacokinetics and overall response to the treatment. This is the first time ANS03 is being tested in humans, making it a critical step in understanding its potential benefits.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors harboring ROS1 or NTRK alterations.
How similar studies have gone: While this is a first-in-human study, previous studies targeting ROS1 and NTRK alterations have shown promising results, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2 * Life expectancy ≥ 12 weeks * Measurable disease per RECIST v1.1 * Adequate organ and marrow function as defined in the protocol * With documentation of ROS1 or NTRK alteration 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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Memorial Sloan Kettering Cancer Center
New York, New York, United States Recruiting -
Research Site
Fuzhou, Fujian, China Recruiting -
Research Site
Guangzhou, Guangdong, China Recruiting -
Research Site
Shanghai, Shanghai Municipality, China Recruiting -
Research Site
Chengdu, Sichuan, China 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.