A Phase 1 Study of ANS03 in People With Advanced Solid Tumors

Full Title

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

Purpose

Researchers want to find the best dose of ANS03 to use and see how well it works in people with solid tumors that metastasized (spread). In addition, their tumors have mutations (changes) in the ROS1 or NTRK1/2/3 genes.

This study includes people with these cancers:

  • Non-small cell lung cancer
  • Gastric (stomach) cancer
  • Breast cancer
  • Esophageal cancer
  • Pancreatic cancer
  • Other types of solid tumors

ANS03 blocks proteins (ROS1 and TRK) that may be too active or found at high levels in your cancer cells. By blocking these proteins, ANS03 may help slow or stop the growth of your cancer. It is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have a metastatic solid tumor that cannot be cured with standard therapy.
  • Have a tumor with an ROS1 or NTRK1/2/3 gene fusion.
  • Have completed prior anti-cancer therapies at least 4 weeks before getting ANS03.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

 

Contact

For more information or to see if you can join this study, please call 646-888-4226.

Protocol

25-099

Phase

Phase I (phase 1)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06716138