Expanded Access for Vepugratinib (LY3866288) in Participants With Fibroblast Growth Factor Receptor 3 (FGFR3) Altered Solid Tumors

NCT07675057 | Unknown

• 2 other identifiers: 27954J4G-MC-Y001
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

Conditions

Urinary Bladder Neoplasms; Neoplasm Metastasis; Carcinoma, Transitional Cell

Keywords

Metastatic Urothelial Carcinoma

Interventions

Vepugratinib DRUG

Administered orally

Also known as: LY3866288

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Neoplasm Metastasis; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Contact Lilly at 1-800-LillyRx (1-800-545-5979)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

The Lilly Answers Center

CONTACT

1-800-LillyRx (1-800-545-5979)

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-05