Expanded Access for Vepugratinib (LY3866288) in Participants With Fibroblast Growth Factor Receptor 3 (FGFR3) Altered Solid Tumors
Sponsor: Eli Lilly and Company
Expanded Access
Sponsor score: 60
ClinicalTrials ID:NCT07675057
This expanded access program allows patients with metastatic urothelial carcinoma or other solid tumors with FGFR3 alterations, who have exhausted approved treatments and are ineligible for ongoing vepugratinib trials, to receive the drug. Vepugratinib is administered orally under the guidance of a treating physician or investigator.
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Program Overview
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
Eligibility Criteria
Inclusion Criteria
- Have metastatic urothelial carcinoma (UC) or other solid tumor with a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration.
- Have exhausted other approved treatments, including erdafitinib for UC.
- Are not eligible for an ongoing vepugratinib clinical trial
Exclusion Criteria
- Currently enrolled in an ongoing clinical study of vepugratinib
- Have a known severe (greater than or equal to (≥) Grade 3) hypersensitivity to any component or excipient of vepugratinib.
- Current evidence of corneal keratopathy or retinal disorder confirmed by ocular examination. Exception: Individuals with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk.
- Significant cardiovascular disease:
- Are pregnant, breastfeeding, or intent to become pregnant during the study or within 6 months of the last dose of study intervention.
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