Clinical trial for Urinary Bladder Neoplasms
Official title FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
ClinicalTrials.gov ID: NCT05614739
What this study is testing
What is LOXO-435?
LOXO-435 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for urinary bladder neoplasms.
Also referred to as LY3866288.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined with other standard medicines that treat cancer. LOXO-435 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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).
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Duarte, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Sacramento, California, United States
- Stanford, California, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Baton Rouge, Louisiana, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Rochester, New York, United States
- The Bronx, New York, United States
- Chapel Hill, North Carolina, United States
+ 46 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Duarte, California, United States; Los Angeles, California, United States; Orange, California, United States; Sacramento, California, United States; Stanford, California, United States and 60 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.