RecruitingUrinary Bladder NeoplasmsNeoplasm MetastasisUreteral Neoplasms

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

Eligible age

18+ yrs

Accepts

All genders

Locations

21 states

Healthy volunteers

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About this study

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.

Sponsor: Eli Lilly and Company

You may qualify if…

✓ 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
✓ Cohort C1: Must have histological diagnosis of a non-urothelial solid tumor malignancy that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration
✓ Measurability of disease:
✓ Cohort A1 and B3: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v1.1)
✓ Cohorts A2, B1, B2, B4, B5, and C1: Measurable disease required as defined by RECIST v1.1

You may not qualify if…

✕ 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
✕ 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
✕ Participants who are 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