ANS03
An investigational treatment for NTRK Fusion Cancer.
The same compound appears under different names depending on the context. Here is how to identify ANS03 wherever you encounter it, plus the key facts at a glance.
- Generic name
- ANS03
- Development codes
- ANS03, ANS-03
- Drug class
- ROS1 and TRK inhibitor (investigational)
- Manufacturer
- Avistone Biotechnology
An investigational oral ROS1 and TRK inhibitor from Avistone in a first-in-human Phase 1 trial for adults with ROS1 or NTRK altered solid tumors, recruiting at Memorial Sloan Kettering in New York and in China. Only preclinical data have been presented.
How ANS03 works
Most approved TRK and ROS1 inhibitors are type I inhibitors that bind the active form of the protein. ANS03 is a type II inhibitor that binds the inactive form, a different pocket that is less affected by the solvent-front and other mutations that make tumors resistant to current drugs. In laboratory and animal studies presented at the AACR meeting in April 2025, it was active against ROS1 and NTRK resistance mutations[2]. Whether that holds in patients is what the Phase 1 trial will show.
Mechanism: Type II inhibitor of ROS1 and TRK designed to bind the inactive form of the protein and overcome resistance mutations
Side effects and safety
No human safety data have been reported; the Phase 1 trial's primary purpose is to measure side effects and find the right dose. Approved ROS1 and TRK inhibitors cause dizziness, altered taste, numbness or tingling and liver enzyme changes, and the trial will watch for those.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Clinical trial results
The Phase 1 trial (NCT06716138) is a first-in-human dose-escalation and expansion study in 96 adults with solid tumors carrying a ROS1 or NTRK alteration. Its primary endpoints are safety and dose-limiting toxicities. It started in March 2025 and is recruiting at Memorial Sloan Kettering Cancer Center in New York and at sites in China[1]. No clinical results have been reported as of October 2026.
Development history
ANS03 is developed by Avistone Biotechnology, a Beijing-based company. Preclinical results were presented at the American Association for Cancer Research annual meeting in April 2025, and the Phase 1 trial opened the same spring.
Explore NTRK Fusion Cancer trials
Other NTRK Fusion Cancer treatments
Where to access ANS03
Investigational: available only through clinical trial enrollment
ANS03 has not been approved by the FDA and is not available by prescription. The only way for a patient to receive ANS03 today is by enrolling in an active clinical trial and meeting that trial's eligibility criteria. Decisions about trial participation should be made with the specialist who manages the patient's condition and knows their current treatment.
Primary active trial
ClinicalTrials.gov record NCT06716138
View full trial record on ClinicalTrials.gov →Trial status, site list, and eligibility are pulled from ClinicalTrials.gov. Confirm current recruitment status and nearest site directly with the study team before traveling.
Common questions about ANS03
▸What is ANS03?
An investigational oral ROS1 and TRK inhibitor from Avistone in a first-in-human Phase 1 trial for adults with ROS1 or NTRK altered solid tumors, recruiting at Memorial Sloan Kettering in New York and in China. Only preclinical data have been presented.
▸How does ANS03 work?
Most approved TRK and ROS1 inhibitors are type I inhibitors that bind the active form of the protein. ANS03 is a type II inhibitor that binds the inactive form, a different pocket that is less affected by the solvent-front and other mutations that make tumors resistant to current drugs. In laboratory and animal studies presented at the AACR meeting in April 2025, it was active against ROS1 and NTRK resistance mutations[2]. Whether that holds in patients is what the Phase 1 trial will show.
▸What are the side effects of ANS03?
No human safety data have been reported; the Phase 1 trial's primary purpose is to measure side effects and find the right dose. Approved ROS1 and TRK inhibitors cause dizziness, altered taste, numbness or tingling and liver enzyme changes, and the trial will watch for those.
▸Is ANS03 FDA approved?
ANS03 is currently in phase 1 clinical trials for NTRK Fusion Cancer. It has not yet received FDA approval.
▸Is ANS03 available to NTRK fusion cancer patients?
Only through its Phase 1 trial (NCT06716138), recruiting adults with ROS1 or NTRK altered solid tumors at Memorial Sloan Kettering Cancer Center in New York and sites in China. It is not approved anywhere.
▸What makes ANS03 different from Augtyro?
ANS03 is a type II inhibitor that binds the inactive form of the TRK and ROS1 proteins, while Augtyro and the first-generation drugs are type I inhibitors that bind the active form. In preclinical work the type II approach stayed active against resistance mutations, but no patient data exist yet.
▸Has ANS03 been tested in people?
The Phase 1 trial that started in March 2025 is the first study in humans. Only laboratory and animal results, presented at AACR in April 2025, have been released.
▸Who can join the ANS03 trial?
Adults with a solid tumor that has a ROS1 or NTRK gene alteration. Eligibility details, including which prior treatments are allowed, are on the ClinicalTrials.gov record for NCT06716138.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- ClinicalTrials.gov. A first-in-human study of ANS03 in patients with advanced solid tumors with ROS1 or NTRK alterations. https://clinicaltrials.gov/study/NCT06716138
- Avistone Biotechnology via Business Wire · 2025-04-15. Avistone announces preclinical results for ANS03, a novel type II ROS1/NTRK inhibitor, in overcoming clinically relevant ROS1/NTRK resistance mutations at AACR Annual Meeting 2025. https://www.businesswire.com/news/home/20250415613561/en/Avistone-Announces-Preclinical-Results-for-ANS03-a-Novel-Type-II-ROS1NTRK-Inhibitor-in-Overcoming-Clinically-Relevant-ROS1NTRK-Resistance-Mutations-at-AACR-Annual-Meeting-2025