Phase 1  | 


Advanced Solid Tumors

FGFR3 Inhibitor

​​​​An Open-Label, Multicenter Study of LOXO-435 (LY3866288) in Advanced Solid Tumor Malignancies With FGFR3 Alterations*

show modal icon NCT05614739
Key Inclusion Criteria
  • Advanced solid tumor malignancy with an FGFR3 pathway alteration on molecular testing in tumor or blood sample that is deemed as actionable
    • Cohort A (dose escalation): Presence of an alteration in FGFR3 or its ligands deemed as a clinically or potentially clinically relevant alteration by the investigator
    • Cohorts B1, B2, and B3 (dose expansion): Histological diagnosis of urothelial cancer that is locally advanced or metastatic with a prespecified activating FGFR3 alteration
    • Cohort C (dose expansion): Histological diagnosis of a non-urothelial solid tumor malignancy that is locally advanced or metastatic with a prespecified activating FGFR3 alteration
  • Measurability of disease:
    • Phase 1a: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
    • Phase 1b: Measurable disease as defined by RECIST v1.1
  • Adequate archival tumor tissue sample available or undergo a screening biopsy, if allowed per country-specific regulations
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Received all standard therapies for which the patient was deemed to be an appropriate candidate by the investigator; OR the patient is declining the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies
    • Cohort B1: Previously treated with an FGFR inhibitor
    • Cohort B2, B3, C1: FGFR inhibitor naïve
Key Exclusion Criteria
  • Primary central nervous system (CNS) malignancy
  • Uncontrolled CNS metastases
  • Current evidence of corneal keratopathy or retinal disorder
  • History and/or current evidence of extensive tissue calcification
  • Any unresolved serious toxicities from prior therapy
  • Significant cardiovascular disease
  • Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF)
  • Active uncontrolled systemic infection or other clinically significant medical conditions
  • Pregnant, lactating, or plan to breastfeed during the study or within 6 months of the last dose of study treatment
This clinical trial is being conducted globally.
LOXO-435 is administered PO.
Pembrolizumab is administered intravenously.
Contact the Lilly Oncology Clinical Trial Navigation Service

Visit for more information on this trial.

Need additional information or have a question:

The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.