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Clinical Trials in the USA / NCT05614739
Recruiting Phase 1

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

NCT05614739 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1
Started
2023-01-12
Last updated
2026-08-20

Condition(s) studied

Urinary Bladder NeoplasmsNeoplasm MetastasisUreteral Neoplasms

Investigational drug(s) / intervention(s)

VepugratinibPembrolizumabenfortumab vedotinTrastuzumab DeruxtecanMidazolamDigoxinRosuvastatin

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Cohort A1, C1, D1, and D2: Locally advanced or metastatic solid tumor malignancy with a qualifying FGFR3 alteration. * Cohort A2, B2, B5 and B7: Urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration. * Cohorts B1 and B4: Urothelial cancer that is locally advanced or metastatic and have received prior erdafitinib. * Cohort B6: Muscle Invasive Bladder Cancer with a qualifying FGFR3 alteration. * Cohort B7: Urothelial cancer that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration and expression of human epidermal growth factor receptor 2 (HER2). * Cohort B8: Low Grade Intermediate Risk Non-Muscle Invasive Bladder cancer and a qualifying FGFR3 genetic alteration. * Measurability of disease: * Cohort A1, D1, and D2: 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, B7, and C1: Measurable disease required as defined by RECIST v1.1. * Cohort B8: Baseline disease which includes at least 1 lesion. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of: * 0 or 1 for Cohorts A1, A2, B5, B6, B7, and B8. * Less than or equal to 2 for Cohorts B1, B2, B4, C1, DI and D2. * Cohort B6: Must be eligible for radical cystectomy plus pelvic lymph node dissection and agree to undergo curative intent standard radical cystectomy plus pelvic lymph node dissection. Exclusion Criteria: * 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. * Cohort D1 only: * Have had renal transplantation. * Have a known history of nephrotic syndrome. * Have uncontrolled fluid overload, including clinically significant ascites, pleural effusion, or peripheral edema. * Have uncontrolled hypertension. * Are on hemodialysis or similar. * Cohort D2 only: * Have a history of: * Ventricular tachycardia or ventricular fibrillation. * Hypertrophic obstructive cardiomyopathy unless managed concurrently with atrial fibrillation. * Wolff-Parkinson-White syndrome. * Second- or third-degree atrioventricular block unless a functioning pacemaker is in place. * Heart rate less than (\<) 50 bpm. * Have any of these medical conditions: * Severe respiratory insufficiency. * Sleep apnea syndrome. * Myasthenia gravis. * Acute narrow-angle glaucoma. * Active liver disease or clinically significant hepatic impairment. * History of myopathy or rhabdomyolysis with any HMG-CoA reductase inhibitor.

Primary outcome measure(s)

Trial sites (82)

FacilityCityRegionStatus
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 USA

Other trials for the same condition

Official registry record

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 USA