Tests vepugratinib in cancers with an FGFR3 gene change
Tests vepugratinib alone or with other cancer drugs in adults with FGFR3-altered bladder cancer.
Plain-language title generated from the registry record
Registry title: FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Key facts
- Where
- Bonn, München, and Tübingen, GermanySee the 3 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or spreading solid tumors, including bladder (urothelial) cancer, that have a qualifying change in the FGFR3 gene. Some groups have extra rules.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Locally advanced or metastatic solid tumor; urothelial cancer (some groups need measurable disease); muscle invasive bladder cancer (one group, needs surgery to remove the bladder); low grade intermediate risk non-muscle invasive bladder cancer (one group).
- Earlier treatment
- Two groups (B1 and B4) need urothelial cancer that has already been treated with erdafitinib. The record asks that serious problems from earlier therapy be resolved.
- Biomarker or test result
- A qualifying FGFR3 gene change. One group also needs HER2 expression.
Main reasons for not taking part
- Primary cancer of the central nervous system (CNS), or untreated or uncontrolled CNS metastases
- Current corneal keratopathy or retinal disorder
- Serious unresolved side effects from earlier therapy
- Significant heart disease or a prolonged QT interval
- Pregnant or breastfeeding, or planning to breastfeed during the study or within 6 months of the last dose
Read by machine on 9 November 2026.
Where in Germany
- Universitaetsklinikum BonnBonn, GermanyNot yet recruiting
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)München, GermanyTaking people
- Universitaetsklinikum TuebingenTübingen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT05614739EU 2022-502755-59-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Any serious unresolved toxicities from prior therapy; Participants with primary central nervous system (CNS) malignancy; Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible; Significant cardiovascular disease; Active uncontrolled systemic infection or other clinically significant medical conditions; 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; Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF); Untreated or uncontrolled CNS metastases; 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.