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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
FGFR3 Inhibitor
LY3866288
Phase
1
Enrolling
A Phase 1, Open-label, Multicenter Study of LY3866288 (LOXO-435) in Locally Advanced or Metastatic Solid Tumors Including Urothelial Cancer with FGFR3 Alterationsa
Related Resources:
Molecule Overview Trial Enrollment
NCT05614739 show modal icon
Key Inclusion Criteria
  • Solid tumor cancer with an FGFR3 pathway alteration (where applicable) on molecular testing in tumor or blood sample that is deemed as actionable
    • Cohort A1 (dose escalation): Presence of an alteration in FGFR3 or its ligands
    • Cohorts A2, B2, B3, and B5: Histological diagnosis of urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration
    • Cohorts B1 and B4: Histological diagnosis of UC that is locally advanced or metastatic
    • Cohort C: Histological diagnosis of a non-urothelial solid tumor malignancy that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration
  • Measurability of disease:
    • Cohorts A1 and B3: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
    • Cohorts A2, B1, B2, B4, B5, and C1: Measurable disease as defined by RECIST v1.1
  • Adequate archival tumor tissue sample available
  • Eastern Cooperative Oncology Group (ECOG) performance status of:
    • 0 or 1 for Cohorts A1, A2, B3, and B5, or
    • ≤2 for Cohorts B1, B2, B4, and C1
  • Prior systemic therapy criteria:
    • Cohorts A1 and C1: Participant has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies
    • Cohorts A2, B2, and B3: Participants must have received at least one prior regimen in the locally advanced or metastatic setting. There is no restriction on number of prior therapies
    • Cohort B1: Participant must have received at least two prior regimens, including erdafitinib and enfortumab vedotin; AND must also have received all other standard therapies deemed appropriate by the treating investigator
    • Cohort B4: Participants must have received at least two prior regimens, including erdafitinib, but have not received enfortumab vedotin; AND must also have received all other standard therapies deemed appropriate by the treating investigator
    • Cohort B5: Participants must not have received prior systemic therapy for locally advanced or metastatic UC
  • FGFR inhibitor specific requirements:
    • Cohorts A1, A2, and B3: Prior FGFR inhibitor treatment is permitted, but not required
    • Cohorts B1 and B4: Participants must have been previously treated with erdafitinib
    • Cohorts B2, B5, and C1: Participants must be FGFR inhibitor naïve
Key Exclusion Criteria
  • Primary central nervous system (CNS) malignancy (glioma)
  • Untreated or uncontrolled CNS involvement
  • Current evidence of corneal keratopathy or retinal disorder
  • Any unresolved serious toxicities from prior therapy, exceptions for individuals with:
    • Alopecia
    • Peripheral neuropathy
    • Hearing loss
    • Grade 2 nail loss
    • Grade ≥2 skin toxicity by body surface area (BSA) alone
    • Endocrinopathies developed due to prior immunotherapies
  • 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
  • Participants who have stopped breastfeeding may be enrolled

Updated clinicaltrials.gov information for NCT05614739 may be pending.

a
This clinical trial is being conducted globally.
b
Administered orally.
c
Administered intravenously.
d
Up to 2 cycles of EV plus pembrolizumab prior to study are allowed for cases where immediate treatment is clinically indicated.
e
Cohorts B3 and B5 will assess safety and tolerability as co-primary endpoints in addition to overall response rate.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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