At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Vepugratinib (drug), Pembrolizumab (drug), enfortumab vedotin (drug), Trastuzumab Deruxtecan (drug)
- How long the study runs
- Study runs about 53 months (dates as stated)
- About the drug or intervention
- Vepugratinib — drug: Oral · Pembrolizumab — drug: IV · enfortumab vedotin — drug: IV · Trastuzumab Deruxtecan — drug: IV · Midazolam — drug: Oral · Digoxin — drug: Oral · Rosuvastatin — drug: Oral
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 677
- Started
- 2023-01-12
- Last checked
- 2026-11
Plain English Summary
What is this study?
- • Testing a new treatment for urinary bladder neoplasms
- • Phase1 - 677 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with urinary bladder neoplasms
Where?
- • Manchester - The Christie NHS Foundation Trust
- • Sheffield - Sheffield Teaching Hospitals NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This is an open-label, multi-center, phase 1 study in participants with FGFR3-altered advanced solid tumor malignancy including metastatic urothelial cancer (UC), muscle-invasive bladder cancer (MIBC), and low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC). The study will be conducted in 2 phases. Phase 1a will assess safety, tolerability, and pharmacokinetics of Vepugratinib to determine the optimal dose for further expansion. Phase 1b will include dose expansion cohorts to evaluate the efficacy and safety of Vepugratinib as monotherapy or in combinations with other medicines that treat cancer.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ as defined by RECIST v1
What the study is looking for
- ✓Cohort A1, C1, D1, and D2: that has grown locally or that has spread solid tumor cancer with a qualifying FGFR3 alteration.
- ✓Cohort A2, B2, B5 and B7: Urothelial cancer (UC) that is that has grown locally or that has spread with a qualifying FGFR3...
- ✓Cohorts B1 and B4: Urothelial cancer that is that has grown locally or that has spread and have received prior erdafitinib.
- ✓Cohort B6: Muscle Invasive Bladder Cancer with a qualifying FGFR3 alteration.
- ✓Cohort B7: Urothelial cancer that is that has grown locally or that has spread with a qualifying FGFR3 genetic alteration and...
Who cannot take part
- ✗Participants with primary central nervous system (CNS) cancer.
- ✗Untreated or uncontrolled CNS metastases.
- ✗Current evidence of corneal keratopathy or retinal disorder. Individuals with not causing symptoms ophthalmic conditions may...
- ✗Any serious unresolved toxicities from prior therapy.
- ✗Significant cardiovascular disease.
See the full criteria
Where Is This Study? (2 UK sites)
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield S10 2SB, United Kingdom
How to Get in Touch
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Sponsor contactCONTACT
Physicians interested in becoming principal investigators please contact
Sponsor contactCONTACT
