Comparing 8 approaches 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
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
- Phase 1
- 8 groups
- Sites in Toronto and Vancouver
- Recruiting
Interventions (7)
- Medication
Vepugratinib
Oral
- Medication
Pembrolizumab
IV
- Medication
enfortumab vedotin
IV
- Medication
Trastuzumab Deruxtecan
IV
- Medication
Midazolam
Oral
- Medication
Digoxin
Oral
- Medication
Rosuvastatin
Oral
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
Princess Margaret Hospital
Toronto
- Recruiting
British Columbia Cancer Agency
Vancouver
Eligibility Criteria
See who this study is looking for42 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +CohortCohortA group of participants sharing a characteristic, followed together.Read more → 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: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → 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
- −Untreated or uncontrolled CNS metastases.
- −Participants with primary central nervous system (CNS) malignancy.
- −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.
- −CohortCohortA group of participants sharing a characteristic, followed together.Read more → 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.
- −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 enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more →.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 8 groups in this study.
Groups A, B, C and G receive Vepugratinib.
Registry label: A: Phase 1a: Cohort A1 Vepugratinib Monotherapy Dose Escalation · B: Phase 1a: Cohort A2 Vepugratinib Monotherapy Dose Optimization · C: Phase 1b: Cohort B1, B2, B4, C1, and D1 Vepugratinib Monotherapy Dose Expansion · G: Phase 1b: NMIBC Cohort B8 Vepugratinib Monotherapy Dose Expansion
Groups D and E receive Vepugratinib, Pembrolizumab and enfortumab vedotin.
Registry label: D: Phase 1b: Cohort B5 Vepugratinib Plus Pembrolizumab Plus Enfortumab Vedotin · E: Phase 1b: MIBC Cohort B6 Vepugratinib Plus Pembrolizumab Plus Enfortumab Vedotin
Group F receives Vepugratinib and Trastuzumab Deruxtecan.
Registry label: F: Experimental: Phase 1b: Cohort B7 Vepugratinib Plus Trastuzumab Deruxtecan
Group H receives one or more of: Vepugratinib, Midazolam, Digoxin and Rosuvastatin.
Registry label: H: Phase 1b: Cohort D2 (Drug to Drug Interaction)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 677 people.
The study is currently expected to finish around June 2027.
The main measurement is taken over: Up to Approximately 30 Months or 2.5 Years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Overall Response Rate (ORR) — measured over Up to Approximately 30 Months or 2.5 Years.
PharmacokineticsPharmacokineticsThe study of how the body absorbs, distributes, and clears a treatment.Read more → (PK) of Vepugratinib: Area Under the Concentration versus Time Curve (AUC) — measured over 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]) — measured over Up to 2 Months.
Complete Response Rate (CRR) in Participants with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG IR NMIBC) — measured over Up to approximately 24 months or 5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05614739 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About VepugratinibDrug
Oral
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PembrolizumabDrug
IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About enfortumab vedotinDrug
IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Trastuzumab DeruxtecanDrug
IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About MidazolamDrug
Oral
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About DigoxinDrug
Oral
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About RosuvastatinDrug
Oral
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to Approximately 30 Months or 2.5 Years.
The study as a whole is currently expected to finish around 2027-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 677 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Toronto, Canada; Vancouver, Canada; Detroit, Michigan, United States; New York, New York, United States; Rochester, New York, United States; The Bronx, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (8)
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
New York University (NYU)
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University
New York, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester - Wilmot Cancer Institute
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.