Investigating ANS03 for advanced solid tumors with specific genetic alterations
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
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 |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Avistone Biotechnology Co., Ltd. Industry-sponsored |
| Locations | 5 sites (New York, New York and 4 other locations) |
| Trial ID | NCT06716138 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with measurable locally advanced or metastatic solid tumors and documented ROS1 or NTRK alterations.
Not a fit: Patients with active infections, untreated CNS metastases, or serious cardiovascular conditions 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 harboring ROS1 or NTRK alterations.
How similar studies have performed: While this is a first-in-human study, previous studies targeting ROS1 and NTRK alterations have shown promising results, indicating potential for success.
Eligibility criteria
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 this trial is running
New York, New York and 4 other locations
- 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
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.