RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-02-10
Study Completion:2029-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06716138

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2
  3. * Life expectancy ≥ 12 weeks
  4. * Measurable disease per RECIST v1.1
  5. * Adequate organ and marrow function as defined in the protocol
  6. * With documentation of ROS1 or NTRK alteration
  1. * Active infection including tuberculosis and HBV, HCV or HIV
  2. * Known active or untreated CNS metastases
  3. * Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression
  4. * Participants with serious cardiovascular or cerebrovascular diseases

Contacts and Locations

Study Contact

Avistone Clinical Study Information Center
CONTACT
8610 84148921
information.center@avistonebio.com

Study Locations (Sites)

Research Site
New York, New York, 10022
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2025-02-10
Study Completion Date2029-03-30

Study Record Updates

Study Start Date2025-02-10
Study Completion Date2029-03-30

Terms related to this study

Keywords Provided by Researchers

  • ROS1/NTRK
  • ANS03

Additional Relevant MeSH Terms

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