RecruitingPhase 1NCT06716138

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


Sponsor

Avistone Biotechnology Co., Ltd.

Enrollment

96 participants

Start Date

Mar 6, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ANS03 for people with locally advanced or metastatic solid tumors harboring a ros1 or ntrk alteration. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGANS03

ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).


Locations(5)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Research Site

Fuzhou, Fujian, China

Research Site

Guangzhou, Guangdong, China

Research Site

Shanghai, Shanghai Municipality, China

Research Site

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT06716138