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

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.

Conditions

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

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Study Overview

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Study Details

Study 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.

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

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

Condition
Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration
Intervention / Treatment

-

Contacts and Locations

New York

Research Site, New York, New York, United States, 10022

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Avistone Biotechnology Co., Ltd.,

Study Record Dates

2029-03-30