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Recruiting NCT06716138

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

Phase I Interventional Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ANS03.
Who it may be relevant to
Registry conditions: Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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]
  • 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)]
Secondary outcome measures (11)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 4 centers
  • Research Site — Fuzhou
  • Research Site — Guangzhou
  • Research Site — Shanghai
  • Research Site — Chengdu
United States · 1 center
  • Memorial Sloan Kettering Cancer Center — New York

Identifiers

NCT: NCT06716138 · ANS03-I-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗