A Phase I/II Study of THE-630 in People with Advanced Gastrointestinal Stromal Tumors

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Full Title

A Phase 1/2 Study of the Safety, Pharmacokinetics and Anti-Tumor Activity of the Oral KIT Inhibitor THE-630 in Patients with Advanced Gastrointestinal Stromal Tumors (GIST)

Purpose

The purpose of this study is to find the highest dose of the investigational drug THE-630 that can be given safely in people with metastatic inoperable gastrointestinal stromal tumors (GIST) that have continued to grow despite standard therapies. THE-630 blocks a range of proteins that cancer cells need to survive and grow. Blocking these proteins may slow or stop the growth of GIST and prevent or delay the development of resistance to treatment. THE-630 is a capsule that is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have metastatic GIST that has continued to grow despite standard therapies (imatinib and at least one of these drugs: sunitinib, regorafenib, ripretinib, or avapritinib) and cannot be surgically removed.
  • At least 2 weeks must pass since the completion of prior therapies and receipt of THE-630.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is open to people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. William Tap at 646-888-4163.

Protocol

21-523

Phase

I/II

Investigator

Co-Investigators