FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company
About this trial
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.
Eligibility criteria
Qualifiers
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 alteration
Cohorts B1 and B4: Histological diagnosis of urothelial cancer that is locally advanced or metastatic
Disqualifiers
Participants with primary central nervous system (CNS) malignancy
Untreated or uncontrolled CNS metastases
Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible
Any serious unresolved toxicities from prior therapy
Trial design
Treatments tested in this trial
- LOXO-435
- Pembrolizumab
- enfortumab vedotin
Treatment groups
535 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov