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

Purpose

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.

Condition

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ANS03 monotherapy
  • Drug: ANS03
    ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).

Recruiting Locations

Memorial Sloan Kettering Cancer Center
New York, New York 10022

More Details

Status
Recruiting
Sponsor
Avistone Biotechnology Co., Ltd.

Study Contact

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