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

Recruiting now · Phase 1

Conditions studied: Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration

In brief

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.

Key facts

Study ID

NCT06716138

Run by

Avistone Biotechnology Co., Ltd.

People needed

96

Starts

2025-03-06

Expected to finish

2029-03-30

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Research Site — Fuzhou, Fujian, China (enrolling)
• Research Site — Guangzhou, Guangdong, China (enrolling)
• Research Site — Shanghai, Shanghai Municipality, China (enrolling)
• Research Site — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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