Recruiting
Phase 1

ANS03

Sponsor:

Avistone Biotechnology Co., Ltd.

Code:

NCT06716138

Conditions

Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ANS03

Study Details

Brief 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.

Conditions

Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration

Study ID

NCT06716138

Start date

Mar 6, 2025

Status verified date

Mar, 2026

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

96 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ANS03 monotherapy

Interventions

ANS03

ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).

Primary outcome measure

  • Incidence of Adverse Events (AEs) [ Time Frame: 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 ]
  • 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) ]
  • 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 ]
  • 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) ]

Central Contacts and Locations

Central contacts

Avistone Clinical Study Information Center

8610 84148921information.center@avistonebio.com

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10022

More Information

Sponsor

Avistone Biotechnology Co., Ltd.

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

  • ROS1/NTRK
  • ANS03
  • ROS1
  • NTRK

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Avistone Biotechnology Co., Ltd. on 2026-03-13.