A Phase 1a Study of LOXO-435 in People with Advanced Solid Tumors Containing FGFR3 Gene Changes


Full Title

An Open-label, Multicenter Study of LOXO-435 (LY3866288) in Advanced Solid Tumor Malignancies with FGFR3 Alterations


The purpose of this study is to find the highest dose of the investigational drug LOXO-435 that can be given safely in people with advanced solid tumors that have come back or continued to grow despite treatment and contain a change in the FGFR3 gene. LOXO-435 targets cells with this abnormality and blocks the activity of FGFR3, a protein that plays a role in cancer growth. Inhibiting this protein could slow or stop the growth of cancer. LOXO-435 is taken orally (by mouth).

Who Can Join

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

  • Participants must have an inoperable or metastatic solid tumor that came back or continued to grow despite treatment and contains a change in the FGFR3 gene.
  • The serious side effects of previous treatments must go away before taking LOXO-435.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.


For more information and to ask about eligibility for this study, please contact the office of Dr. Gopakumar Iyer at 646-888-4737.




Phase I (phase 1)

Disease Status

Relapsed or Refractory




ClinicalTrials.gov ID