A Phase III Study of Sunitinib with or without CGT9486 in People with Inoperable or Metastatic Gastrointestinal Stromal Tumors

Full Title

(PEAK) A Phase 3 Randomized, Open-label, Multicenter Clinical Study of CGT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable or Metastatic Gastrointestinal Stromal Tumors (WCG)

Purpose

This study is assessing the effectiveness of adding the investigational drug CGT9486 (also known as bezuclastinib) to sunitinib treatment in people with inoperable or metastatic gastrointestinal stromal tumors (GIST) whose disease continues to grow despite treatment and who cannot tolerate imatinib. CGT9486 is designed to block mutations in a gene called KIT, which can cause cancer and promote cell growth. By blocking these mutations, CGT9486 may kill cancer cells with the mutation and/or stop the tumor from growing. 

Participants will be randomly assigned to one of several treatment groups in which sunitinib is given alone or with CGT9486. Both medications are taken orally (by mouth).

Contact

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

Protocol
22-229
Phase
Phase III (phase 3)
Disease Status
Relapsed or Refractory
Investigator
Co-Investigators
ClinicalTrials.gov ID
NCT05208047