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

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

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.

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