A Phase I/II Study of CFT8634 in People with Synovial Sarcoma or Other Solid Tumors


Full Title

A Phase 1/2 Open-Label, Multicenter Study to Characterize the Safety and Tolerability of CFT8634 in Subjects With Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors


The purpose of this study is to find the highest dose of the investigational drug CFT8634 that can be given safely to patients with advanced synovial sarcoma and other solid tumors than contain a mutation in the SMARCB1 gene and have continued to grow despite treatment. This gene makes the SMARCB1 protein, which plays a role in preventing tumor growth.

When there is a mutation in the SMARCB1 gene, the SMARCB1 protein stops working and cancer cells are able to survive and grow. They become dependent on BRD9, a protein that promotes tumor growth. CFT8634 is designed to break down BRD9. By destroying this protein, CFT8634 may slow or stop cancer growth. CFT8634 is taken orally (by mouth).

Who Can Join

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

  • Participants must have inoperable or metastatic synovial sarcoma or other solid tumor that has come back or continued to grow despite treatment.
  • Patients’ tumors must contain a mutation in the SMARCB1 gene.
  • The serious side effects of previous treatments must go away before CFT8634 is given.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 16 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.





Disease Status

Newly Diagnosed & Relapsed/Refractory



ClinicalTrials.gov ID