A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

March 11, 2026 updated by: Avistone Biotechnology Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Research Site
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Research Site
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Research Site
  • United States
    • New York
      • New York, New York, United States, 10022
        • Recruiting
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ANS03 monotherapy
Drug: ANS03
ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the time of first dose to 28 days post last dose of ANS03
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
From time of first dose to 28 days post last dose of ANS03
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
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
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
From time of first dose to 28 days post last dose of ANS03
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
From date of first dose of ANS03 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression
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)
The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1)
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)]
The time from first dose until RECIST 1.1 defined disease progression or death due to any cause
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)
The time from the date of the first dose of study treatment until death due to any cause
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
Measurement of plasma concentrations of ANS03, total antibody and total unconjugated warhead
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
Measurement of PK parameters: Area under the concentration time curve (AUC)
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
Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)
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
Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)
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
Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance)
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
Measurement of PK parameters: Terminal elimination half-life (t 1/2)
From date of first dose up until 28 days post last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avistone Biotechnology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2025

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

March 30, 2029

Study Registration Dates

First Submitted

November 29, 2024

First Submitted That Met QC Criteria

November 29, 2024

First Posted (Actual)

December 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANS03-I-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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