RecruitingPhase 1NCT05614739

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

FORAGER-1: A Phase 1, Open-Label, Multicenter Study of Vepugratinib (LY3866288; LOXO-435) in Locally Advanced or Metastatic Solid Tumors Including Urothelial Cancer and Muscle Invasive Bladder Cancer With FGFR3 Alterations

Sponsor

Eli Lilly and Company

Enrollment

677 participants

Start Date

Jan 12, 2023

Study Type

INTERVENTIONAL

Conditions

Urinary Bladder Neoplasms Neoplasm Metastasis Ureteral Neoplasms

Summary

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of Vepugratinib by itself or when it is combined with other medicines that treat cancer. Vepugratinib 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). Study participation could last up to approximately 6 years, depending on which part of the study you join.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called LOXO-435 (LY3866288) in people whose cancer has a change (mutation or alteration) in a gene called FGFR3, which can drive cancer growth. The study includes bladder cancer and other solid tumors. **You may be eligible if...** - You have a solid tumor cancer with a confirmed FGFR3 gene alteration detected on a tumor or blood test - You have locally advanced or metastatic cancer that has progressed despite standard treatments - Your general health score is 0–2 (able to care for yourself and perform some activities) - You have at least one measurable tumor on imaging (in most groups) **You may NOT be eligible if...** - Your cancer does not have an FGFR3 alteration - You have not tried or are still eligible for standard treatments (in most groups) - Your organ function is insufficient to safely receive the drug - You have uncontrolled serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVepugratinib

Oral

DRUGPembrolizumab

DRUGenfortumab vedotin

DRUGTrastuzumab Deruxtecan

DRUGMidazolam

Oral

DRUGDigoxin

Oral

DRUGRosuvastatin

Oral

Locations(82)

University of Arizona - Cancer Center

Tucson, Arizona, United States

City of Hope

Duarte, California, United States

University of California, Los Angeles (UCLA) - Division of Hematology-Oncology

Los Angeles, California, United States

University of California - Irvine

Orange, California, United States

University of California (UC) Davis Comprehensive Cancer Center

Sacramento, California, United States

Stanford Medicine Cancer Center

Stanford, California, United States

Advent Health

Orlando, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

The University of Chicago Medical Center (UCMC)

Chicago, Illinois, United States

Indiana University (IU) Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Johns Hopkins Kimmel Cancer Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Washington University in St. Louis

St Louis, Missouri, United States

New York University (NYU)