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
Avistone Biotechnology Co., Ltd.
96 participants
Mar 6, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria4
- 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
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Interventions
ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06716138