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A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations

Cancer Type
Solid Tumor
Unknown Primary
Trial Phase
Phase II
6 Years and older, Male and Female
Study Type
Protocol IDs
CR108661 (primary)
Study Sponsor
Janssen Research & Development, LLC


The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall
response rate (ORR) in adult and pediatric participants with advanced solid tumors with
fibroblast growth factor receptor (FGFR) alterations (mutations or gene fusions). It will
also evaluate ORR in pediatric participants with advanced solid tumors and FGFR alterations.


Erdafitinib is a selective and potent pan FGFR 1-4 inhibitor with demonstrated clinical
activity in participants with metastatic urothelial cancer and cholangiocarcinoma identified
to have alterations in the FGFR pathway. This study targets the underlying altered biology of
FGFR-driven tumors irrespective of solid tumor histology subtype. The study consists of
screening phase, treatment phase and the post treatment follow-up phase (from the end of
treatment visit until the participants has died, withdraws consent, is lost to follow-up, or
the end of study, whichever comes first). End of study is defined as 4 years from enrollment
of last participant into study or last follow-up visit of last participant, whichever occurs
first. Currently this study is recruiting pediatric participants only.


  1. Histologic demonstration of an unresectable, locally advanced, or metastatic solid tumor malignancy with an fibroblast growth factor receptor (FGFR) mutation or FGFR gene fusion
  2. Measurable disease
  3. Participant must have received at least one prior line of systemic therapy in the advanced, unresectable, or metastatic setting; or is a child or adolescent participant with a newly-diagnosed solid tumor and no acceptable standard therapies
  4. Documented progression of disease, defined as any progression that requires a change in treatment, prior to full study screening

Treatment Sites in Georgia

Emory University Hospital - Atlanta

1364 Clifton Road NE
Atlanta, GA 30322

University Cancer and Blood Center, LLC - Athens Medical Oncology

3320 Old Jefferson Road
Building 700
Athens, GA 30607
706-353-2990 x279

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE


Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.