Atlanta, GANCT05614739Now EnrollingIRB Ready

Urinary Bladder Neoplasms Clinical Trial in Atlanta, GA

Access cutting-edge urinary bladder neoplasms treatment through this clinical trial at a research site in Atlanta. Study-provided care at no cost to qualified participants.

Sponsored by Eli Lilly and Company

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Expert Care in Atlanta

Access urinary bladder neoplasms specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related urinary bladder neoplasms treatment provided free

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Check if you qualify for this urinary bladder neoplasms clinical trial in Atlanta, GA

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Why Participate?

  • No-Cost Study Care

  • Local to Atlanta

    Convenient for GA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Atlanta site if eligible
  4. 4Begin participation

About This Urinary Bladder Neoplasms Study in Atlanta

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). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse.

Sponsor: Eli Lilly and Company

Who Can Participate

Inclusion Criteria

Have solid tumor cancer with an FGFR3 pathway alteration on molecular testing in tumor or blood sample that is deemed as actionable
Cohort A1: Presence of an alteration in FGFR3 or its ligands
Cohort A2, B2, B3, and B5: Histological diagnosis of urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration
Cohorts B1 and B4: Histological diagnosis of urothelial cancer that is locally advanced or metastatic
Cohort C1: Must have histological diagnosis of a non-urothelial solid tumor malignancy that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration
Measurability of disease:
Cohort A1 and B3: 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, and C1: Measurable disease required as defined by RECIST v1.1
Have adequate tumor tissue sample available. Participants with inadequate tissue sample availability may still be considered for enrollment upon review
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for Cohorts A1, A2, B3, and B5
Less than or equal to 2 for Cohorts B1, B2, B4, and C1
Prior Systemic Therapy Criteria:
Cohort A1/C1: Participant has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating Investigator; OR the participant is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies.
Cohort A2, B2, B3 participants must have received at least one prior regimen, and cohorts B1 and B4 participants at least 2 prior regimens, in the locally advanced or metastatic setting
There is no restriction on number of prior therapies
Cohort B5: Participants have not received prior systemic therapy for locally advanced or metastatic UC
FGFR inhibitor specific requirements:
Cohort A1/A2/B3: Prior FGFR inhibitor treatment is permitted but not required
Cohort B1/B4: Participants must have been previously treated with erdafitinib
Cohort B2, B5, and C1: Participants must be FGFR inhibitor naïve

Exclusion Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Atlanta?

Yes, this clinical trial (NCT05614739) has an active research site in Atlanta, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Urinary Bladder Neoplasms Treatment Options in Atlanta, GA

If you're searching for urinary bladder neoplasms treatment options in Atlanta, GA, this clinical trial (NCT05614739) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Atlanta research site is actively enrolling participants for this clinical trial. You'll receive care from experienced urinary bladder neoplasms specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all urinary bladder neoplasms clinical trials near you to find additional studies recruiting in your area.

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