FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined with other standard medicines that treat cancer. LOXO-435 may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse.

Trial Details

NCT ID
NCT05614739
Phase
PHASE1
Sponsor
Eli Lilly and Company
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • LOXO-435
  • Pembrolizumab
  • enfortumab vedotin
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Duarte, California, United States|34.13945,-117.97729
  • Orange, California, United States|33.78779,-117.85311
  • Orlando, Florida, United States|28.53834,-81.37924
  • Atlanta, Georgia, United States|33.749,-84.38798

Key Eligibility Criteria

  • Have solid tumor cancer with an FGFR3 pathway alteration on molecular testing in tumor or blood sample that is deemed as actionable
  • Cohort A1: Presence of an alteration in FGFR3 or its ligands
  • Cohort A2, B2, B3, and B5: Histological diagnosis of urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic …
  • Cohorts B1 and B4: Histological diagnosis of urothelial cancer that is locally advanced or metastatic

For full eligibility, visit ClinicalTrials.gov.

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