A Phase II Study of Debio 1347 for Patients Who Have Cancer with an FGFR Mutation


Full Title

A Phase II Basket Study of the Oral Selective Pan-FGFR Inhibitor Debio 1347 in Subjects with Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3


FGFR 1, FGFR 2, and FGFR 3 are molecules that form “receptors” on the surface of cells. These receptors are molecular switches that, when activated, can fuel cellular growth in various ways. FGFR “fusions” are genetic mistakes that occur when one part of the machinery of a cell attaches abnormally to another part, and the new (fused) part causes abnormal tumor growth.

In this study, researchers are evaluating the effectiveness and safety of the investigational drug Debio 1347 in patients with advanced solid tumors that contain an FGFR fusion. Debio 1347 works by shutting off these fusions. It is taken orally (by mouth).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a metastatic or inoperable solid tumor that contains an FGFR fusion and has continued to grow despite treatment. Most patients in this study will have bladder cancer or bile duct cancers. Patients with other cancers may also participate, including but not limited to non-small cell lung cancer, head and neck cancer, thyroid cancer, oral cancer, breast cancer, and prostate cancer.
  • At least 2 weeks must pass since the completion of prior therapy (3 weeks since immunotherapy) and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. David Hyman at 646-888-4544.