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Kinase Inhibitor
LOXO-435 for Bladder Cancer
Phase 1
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have histological diagnosis of a non-urothelial solid tumor malignancy that is locally advanced or metastatic with a prespecified activating FGFR3 alteration for Cohort C (Dose Expansion)
Have solid tumor cancer with an FGFR3 pathway alteration on molecular testing in tumor or blood sample that is deemed as actionable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 30 months or 2.5 years
Awards & highlights
Study Summary
This trial tests a drug to treat cancer of the urinary system & other solid tumors w/ a gene change. Participation could last up to 2.5 years.
Who is the study for?
This trial is for adults with advanced or metastatic solid tumors, including bladder cancer, that have a specific gene change (FGFR3). They must have tried all standard treatments or refuse them and be in good physical condition. Pregnant women and those with uncontrolled brain metastases, serious heart conditions, unresolved side effects from prior therapies, or certain eye disorders cannot join.Check my eligibility
What is being tested?
The study tests LOXO-435's safety and effectiveness on cancers linked to the FGFR3 gene alteration. Participants will also receive Pembrolizumab. The trial involves different cohorts based on previous treatments and genetic profiles of the tumors. It can last up to 2.5 years.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation by Pembrolizumab such as fatigue, skin issues, inflammation of organs; LOXO-435 may cause similar effects due to its targeted action on cancer cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced or has spread, and tests show a specific FGFR3 gene change.
Select...
My cancer has a specific genetic change in FGFR3 that can be targeted for treatment.
Select...
I have been treated with an FGFR inhibitor for my condition.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 30 months or 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 30 months or 2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1a: To determine the recommended phase 2 dose (RP2D)/optimal dose of LOXO-435: Safety, number of participants with dose-limiting toxicities (DLTs)
Heart rate
Secondary outcome measures
Change from baseline in bladder-related symptoms, measured by Functional Assessment of Cancer Therapy - Bladder (FACT-Bl) subscale (BlCS)
Change from baseline in physical function, measured by FACT- Physical Well-being Scale (PWB) subscale
Plasma
+6 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Phase 1b: Cohort C1 LOXO-435 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
LOXO-435 administered orally to participants with advanced solid tumors who have not received a prior FGFR inhibitor.
Group II: Phase 1b: Cohort B3 LOXO-435 Plus PembrolizumabExperimental Treatment2 Interventions
LOXO-435 administered orally in combination with pembrolizumab administered intravenously (IV) to participants with FGFR3-altered advanced urothelial carcinoma who have not received a prior FGFR inhibitor.
Group III: Phase 1b: Cohort B2 LOXO-435 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
LOXO-435 administered orally to participants with FGFR3-altered advanced urothelial carcinoma who have not received a prior FGFR inhibitor.
Group IV: Phase 1b: Cohort B1 LOXO-435 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
LOXO-435 administered orally to participants with FGFR3-altered advanced urothelial carcinoma who were previously treated with an FGFR inhibitor.
Group V: Phase 1a: Cohort A2 LOXO-435 Monotherapy Dose OptimizationExperimental Treatment1 Intervention
LOXO-435 administered orally to participants with FGFR3-altered advanced urothelial carcinoma. (Cohort to be implemented as needed, based on Sponsor's discretion.)
Group VI: Phase 1a: Cohort A1 LOXO-435 Monotherapy Dose EscalationExperimental Treatment1 Intervention
LOXO-435 administered orally to participants with FGFR3-altered advanced solid tumors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,617 Previous Clinical Trials
3,201,020 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,514 Total Patients Enrolled
Loxo Oncology, Inc.Industry Sponsor
66 Previous Clinical Trials
9,689 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has a specific genetic change in FGFR3 that can be targeted for treatment.I have a serious heart condition.Your heart's electrical activity takes longer than normal to reset between beats.I have had at least one treatment for my advanced or metastatic cancer.I may or may not have been treated with FGFR inhibitors before.My advanced bladder cancer has a specific FGFR3 gene change.I don't have any serious side effects from past treatments that haven't gone away.I have a stored tumor sample or can have a biopsy if needed.I do not have any uncontrolled infections or serious health issues.My cancer is advanced or has spread, and tests show a specific FGFR3 gene change.I have never taken FGFR inhibitor medication for my condition.I have tried all standard treatments for my condition, or there are none available.My cancer has a change in the FGFR3 gene or its partners.My bladder cancer is advanced or has spread, and tests show a specific FGFR3 gene change.I have been treated with an FGFR inhibitor for my condition.You need to have a specific amount of measurable disease as defined by the RECIST v1.1 criteria for certain parts of the study.I have a history or current signs of extensive tissue calcification.I have or might have untreated brain metastases.I have a primary brain tumor.I have a current eye condition affecting my cornea or retina.I am fully active or restricted in physically strenuous activity but can do light work.Your disease can be measured or not measured using specific guidelines for the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1a: Cohort A1 LOXO-435 Monotherapy Dose Escalation
- Group 2: Phase 1b: Cohort B1 LOXO-435 Monotherapy Dose Expansion
- Group 3: Phase 1a: Cohort A2 LOXO-435 Monotherapy Dose Optimization
- Group 4: Phase 1b: Cohort B3 LOXO-435 Plus Pembrolizumab
- Group 5: Phase 1b: Cohort C1 LOXO-435 Monotherapy Dose Expansion
- Group 6: Phase 1b: Cohort B2 LOXO-435 Monotherapy Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there room to join this experiment for prospective volunteers?
"Based on the information available from clinicaltrials.gov, this study is no longer recruiting participants--the trial was initially posted in December of 2022 and revised for the last time shortly after. Despite this, there are over 3200 other medical trials that are presently enlisting patients."
Answered by AI
Is it safe to expose individuals to Phase 1b: Cohort C1 LOXO-435 Monotherapy Dose Expansion?
"Given the limited clinical data in support of efficacy and safety, our team at Power rated Phase 1b: Cohort C1 LOXO-435 Monotherapy Dose Expansion as a score of 1."
Answered by AI
What end goal are researchers striving to achieve with this experiment?
"This medical trial's principal goal is to gauge the preliminary antitumor activity of LOXO-435, which will be evaluated by overall response rate (ORR). Further objectives include assessing a patient's overall survival (OS), tracking their minimum plasma concentration (Cmin) and determining the duration of response per investigator assessed RECIST 1.1 over a 21 day cycle with LOXO-435 treatment."
Answered by AI
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