NCT06716138PHASE1Recruiting

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

Avistone Biotechnology Co., Ltd.

Start Date

3/6/2025

Completion Date

3/30/2029

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

ANS03

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Conditions

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

Locations

Memorial Sloan Kettering Cancer Center

New York, New York 10022

United States

Research Site

Fuzhou, Fujian

China

Research Site

Guangzhou, Guangdong

China

Research Site

Shanghai, Shanghai Municipality

China

Research Site

Chengdu, Sichuan

China