NCT06716138 · Avistone Biotechnology Co., Ltd.
A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors
What this study is about
This is a first-in-human Phase I, multi-center, where both patients and doctors know the treatment given study of ANS03 in patients with advanced solid tumors. The study evaluates the safety, tolerability, preliminary efficay, how the drug moves through the body, anti-tumor activity of ANS03 as treatment given alone.
View original scientific description
This is a first-in-human Phase I, multi-center, open-label study of ANS03 in patients with advanced solid tumors. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS03 as monotherapy.
Interventions
DRUG
ANS03
ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).
Primary outcome measures
Incidence of Adverse Events (AEs)
Time frame: From the time of first dose to 28 days post last dose of ANS03
Number of patients with adverse events by system organ class and preferred term
Incidence of Serious Adverse Events (SAEs)
Time frame: From time of first dose to 28 days post last dose of ANS03
Number of patients with serious adverse events by system organ class and preferred term
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Time frame: From time of first dose of ANS03 to end of DLT period (approximately 30 days)
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Incidence of baseline laboratory finding, ECG and vital signs changes
Time frame: From time of first dose to 28 days post last dose of ANS03
measured by laboratory and vital sign variables over time including change from baseline
Proportion of patients with radiological response (ORR)
Time frame: From date of first dose of ANS03 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)
Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2026 · Source of record for eligibility and locations