SARC044 Completes Enrollment

SARC is pleased to announce the successful completion of patient enrollment for SARC044, a Phase II clinical trial evaluating the combination of bezuclastinib and sunitinib in patients with gastrointestinal stromal tumors (GIST) who have progressed on sunitinib alone.

The study, led by Dr. Candace Haddox (Dana-Farber Cancer Institute), included the following enrolling sites:

• Dana-Farber Cancer Institute, Boston, MA, USA
• Fox Chase Cancer Center, Philadelphia, PA, USA
• Oregon Health & Science University, Portland, OR, USA
• University of Miami Sylvester Comprehensive Cancer Center, Miami, FL, USA

SARC044 is assessing the safety and efficacy of this combination in patients with KIT exon 9 or 11-mutant GIST. The trial also incorporated advanced correlative studies—including circulating tumor DNA (ctDNA) analysis, PET/CT imaging, and tumor biopsies—to explore mechanisms of resistance and response. The study’s researchers are analyzing the data and preparing their findings for presentation and publication in the first half of 2026.

SARC sponsors (and runs) investigator-initiated, Phase I to III clinical trials for sarcoma in the United States and internationally. For more information, please visit the SARC Clinical Trials webpage.