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NCT Number: NCT06716138

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Fuzhou, Fujian, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANS03

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Avistone Clinical Study Information Center

CONTACT

[email protected]

8610 84148921

Sponsors and collaborators

Lead sponsor

Avistone Biotechnology Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Dec 4, 2024
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.