Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK AlterationPhase 1NCT06716138
A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing ANS03 in people with Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration, run by Avistone Biotechnology Co., Ltd. at 5 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration
- What is being tested?
- ANS03
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 6 Mar 2025to 30 Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
China4 sites, 4 recruiting
- Recruiting
Research Site
Chengdu, Sichuan
- Recruiting
Research Site
Fuzhou, Fujian
- Recruiting
Research Site
Guangzhou, Guangdong
- Recruiting
Research Site
Shanghai, Shanghai Municipality
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
About this study
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
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.
- Being tested
- ANS03
- Keywords
- ROS1/NTRK, ANS03, ROS1, NTRK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANS03Drug
ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).
| Study group | Role | What they receive |
|---|---|---|
| ANS03 monotherapy | Experimental | Not described Receives: Drug: ANS03 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Number of patients with adverse events by system organ class and preferred term
Measured: From the time of first dose to 28 days post last dose of ANS03
Incidence of Serious Adverse Events (SAEs)
Number of patients with serious adverse events by system organ class and preferred term
Measured: From time of first dose to 28 days post last dose of ANS03
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Measured: From time of first dose of ANS03 to end of DLT period (approximately 30 days)
Incidence of baseline laboratory finding, ECG and vital signs changes
measured by laboratory and vital sign variables over time including change from baseline
Measured: From time of first dose to 28 days post last dose of ANS03
Proportion of patients with radiological response (ORR)
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
Measured: From date of first dose of ANS03 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)
Secondary outcomes (11)
Objective Response Rate (ORR)
The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)
Measured: From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Duration of Response (DoR)
The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression
Measured: From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Disease Control Rate (DCR)
The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1)
Measured: From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Progression free Survival (PFS)
The time from first dose until RECIST 1.1 defined disease progression or death due to any cause
Measured: From date of first dose of ANS03 up until date of progression or death due to any cause (approximately 2 years)]
Overall Survival (OS)
The time from the date of the first dose of study treatment until death due to any cause
Measured: From date of first dose of ANS03 up until the date of death due to any cause (approximately 2 years)
Pharmacokinetics of ANS03: Plasma PK concentrations
Measurement of plasma concentrations of ANS03, total antibody and total unconjugated warhead
Measured: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS03: Area under the concentration time curve (AUC)
Measurement of PK parameters: Area under the concentration time curve (AUC)
Measured: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS03: Maximum plasma concentration of the study drug (C-max)
Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)
Measured: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS03: Time to maximum plasma concentration of the study drug (T-max)
Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)
Measured: Frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS03: Clearance
Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance)
Measured: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS03: Half-life
Measurement of PK parameters: Terminal elimination half-life (t 1/2)
Measured: From date of first dose up until 28 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start6 Mar 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK AlterationStudies of the same condition, open and under way.
- More trials run by Avistone Biotechnology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avistone Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716138
- Sponsor's protocol ID
- ANS03-I-01
- Status last verified
- Mar 2026
- First submitted
- 29 Nov 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06716138
- Acronym / sponsor ID
- ANS03-I-01
- Keywords
- ROS1/NTRK, ANS03, ROS1, NTRK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Avistone Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANS03 monotherapy | Experimental | Drug: ANS03 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANS03ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor). | Drug | ANS03 monotherapy |
Primary outcome
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
11 secondary outcomes
Objective Response Rate (ORR)
Time frame: From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Duration of Response (DoR)
Time frame: From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Disease Control Rate (DCR)
Time frame: From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Progression free Survival (PFS)
Time frame: From date of first dose of ANS03 up until date of progression or death due to any cause (approximately 2 years)]
Overall Survival (OS)
Time frame: From date of first dose of ANS03 up until the date of death due to any cause (approximately 2 years)
Pharmacokinetics of ANS03: Plasma PK concentrations
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS03: Area under the concentration time curve (AUC)
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS03: Maximum plasma concentration of the study drug (C-max)
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS03: Time to maximum plasma concentration of the study drug (T-max)
Time frame: Frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS03: Clearance
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS03: Half-life
Time frame: From date of first dose up until 28 days post last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ANS03 in people with Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration, run by Avistone Biotechnology Co., Ltd. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avistone Clinical Study Information Center (8610 84148921, information.center@avistonebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: From the time of first dose to 28 days post last dose of ANS03). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.