FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Condition(s) studied
Investigational drug(s) / intervention(s)
Vepugratinib: Oral
Pembrolizumab: IV
enfortumab vedotin: IV
Trastuzumab Deruxtecan: IV
Midazolam: Oral
Digoxin: Oral
Rosuvastatin: Oral
Study 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
Primary outcome measure(s)
- Overall Response Rate (ORR) — Up to Approximately 30 Months or 2.5 Years
- Pharmacokinetics (PK) of Vepugratinib: Area Under the Concentration versus Time Curve (AUC) — Up to 2 Months
- PK of Midazolam, Rosuvastatin, and Digoxin Administered Alone and in the Presence of Vepugratinib: Area Under the Concentration versus Time Curve (AUC[0-inf]) — Up to 2 Months
- Complete Response Rate (CRR) in Participants with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG IR NMIBC) — Up to approximately 24 months or 5 years
Trial sites (82)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Arizona - Cancer Center | Tucson | Arizona | Recruiting |
| City of Hope | Duarte | California | Recruiting |
| University of California, Los Angeles (UCLA) - Division of Hematology-Oncology | Los Angeles | California | Recruiting |
| University of California - Irvine | Orange | California | Recruiting |
| University of California (UC) Davis Comprehensive Cancer Center | Sacramento | California | Recruiting |
| Stanford Medicine Cancer Center | Stanford | California | Recruiting |
| Advent Health | Orlando | Florida | Recruiting |
| Emory University Hospital | Atlanta | Georgia | Recruiting |
| The University of Chicago Medical Center (UCMC) | Chicago | Illinois | Recruiting |
| Indiana University (IU) Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | Recruiting |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | Recruiting |
| Ochsner Clinic Foundation | New Orleans | Louisiana | Recruiting |
| Johns Hopkins Kimmel Cancer Center | Baltimore | Maryland | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | Recruiting |
| Washington University in St. Louis | St Louis | Missouri | Recruiting |
| New York University (NYU) | New York | New York | Recruiting |
| Weill Cornell Medicine | New York | New York | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | Recruiting |
| Columbia University | New York | New York | Recruiting |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| University of Rochester - Wilmot Cancer Institute | Rochester | New York | Recruiting |
| Montefiore Medical Center | The Bronx | New York | Recruiting |
| University of North Carolina (UNC) - Chapel Hill | Chapel Hill | North Carolina | Recruiting |
| University of Cincinnati Medical Center (UCMC) | Cincinnati | Ohio | Recruiting |
| The Ohio State University (OSU) | Columbus | Ohio | Recruiting |
| University of Oklahoma - Health Sciences Center | Oklahoma City | Oklahoma | Recruiting |
| Penn Medicine Lancaster General Hospital - Ann B. Barshinger Cancer Institute | Lancaster | Pennsylvania | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| Thomas Jefferson University | Philadelphia | Pennsylvania | Recruiting |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | Recruiting |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | Recruiting |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | Recruiting |
| Sarah Cannon and HCA Research Institute | Nashville | Tennessee | Recruiting |
| Tennessee Oncology | Nashville | Tennessee | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Recruiting |
| University of Texas Southwestern | Dallas | Texas | Recruiting |
| Texas Oncology, P.A | Dallas | Texas | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| University of Utah | Salt Lake City | Utah | Recruiting |
+ 42 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile → 📄 Padcev (enfortumab vedotin) drug profile → 📄 Enhertu (trastuzumab deruxtecan) drug profile → 📄 Crestor (rosuvastatin) drug profile →More Eli Lilly and Company trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05614739 on ClinicalTrials.gov ↗ ← All trials in the UK