Bladder Cancer Clinical Trial

A Study of LOXO-435 in Participants With Cancer With a Change in a Gene Called FGFR3

Summary

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435. 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.

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Full Description

This is an open-label, multi-center, phase 1a/b study in participants with FGFR3-altered advanced solid tumors, including metastatic urothelial cancer (UC). The study will be conducted in 2 phases: Dose escalation and dose optimization (1a) and dose expansion (1b). Phase 1a will include up to 2 cohorts to assess safety, tolerability, and pharmacokinetics of LOXO-435 to determine the recommended phase 2 dose (RP2D) (or optimal dose). Phase 1b will include 4 dose expansion cohorts of participants with prespecified activating FGFR3 alterations to evaluate the efficacy and safety of LOXO-435 at the RP2D. Cohort B will enroll pts with metastatic UC and includes three cohorts to evaluate LOXO-435 as monotherapy (B1, B2) and in combination with pembrolizumab (B3). Cohort C will enroll pts with non-UC advanced solid tumors and includes a cohort to evaluate LOXO-435 as monotherapy (C1).

View Eligibility Criteria

Eligibility Criteria

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 (Dose Escalation): Presence of an alteration in FGFR3 or its ligands.
Cohort A2 (Dose Optimization): Histological diagnosis of urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 alteration.
Cohorts B1, B2 and B3 (Dose Expansion): Histological diagnosis of urothelial cancer that is locally advanced or metastatic with a prespecified activating FGFR3 alteration.
Cohort C (Dose Expansion): Must have histological diagnosis of a non-urothelial solid tumor malignancy that is locally advanced or metastatic with a prespecified activating FGFR3 alteration.

Measurability of disease:

Cohort A1: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v1.1)
Cohorts A2, B1, B2, B3, and C1: Measurable disease required as defined by RECIST v1.1
Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country-specific regulations.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

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/B1/B2/B3: Participants must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.

FGFR inhibitor specific requirements:

Cohort A1/A2: Prior FGFR inhibitor treatment is permitted, but not required.
Cohort B1: Participants must have been previously treated with a FGFR inhibitor.
Cohort B2, B3, C1: Participants must be FGFR inhibitor naïve.

Exclusion Criteria:

Participants with primary central nervous system (CNS) malignancy.
Known or suspected history of uncontrolled CNS metastases.
Current evidence of corneal keratopathy or retinal disorder.
Have a history and/or current evidence of extensive tissue calcification.
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.

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

180

Study ID:

NCT05614739

Recruitment Status:

Recruiting

Sponsor:

Eli Lilly and Company

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There are 42 Locations for this study

See Locations Near You

City of Hope Medical Center
Duarte California, 91010, United States More Info
Contact
855-569-6305
University of California Los Angeles
Santa Monica California, 90404, United States More Info
Contact
855-569-6305
Advent Health
Orlando Florida, 32804, United States More Info
Contact
855-569-6305
Emory University
Atlanta Georgia, 30322, United States More Info
Contact
855-569-6305
The University of Chicago Medical Center
Chicago Illinois, 60637, United States
Johns Hopkins Kimmel Cancer Center
Baltimore Maryland, 21231, United States More Info
Contact
855-569-6305
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Contact
855-569-6305
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
Contact
855-569-6305
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Contact
855-569-6305
New York University
New York New York, 10016, United States More Info
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855-569-6305
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States More Info
Contact
855-569-6305
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Contact
855-569-6305
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States More Info
Contact
855-569-6305
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States More Info
Contact
855-569-6305
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Contact
855-569-6305
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States More Info
Contact
855-569-6305
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States More Info
Contact
855-569-6305
Sarah Cannon and HCA Research Institute
Nashville Tennessee, 37203, United States More Info
Contact
855-569-6305
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Contact
855-569-6305
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Contact
855-569-6305
University of Utah
Salt Lake City Utah, 84132, United States More Info
Contact
855-569-6305
GenesisCare North Shore
Saint Leonards New South Wales, 2065, Australia More Info
Contact
855-569-6305
Kinghorn Cancer Centre
Darlinghurst , NSW 2, Australia More Info
Contact
855-569-6305
British Columbia Cancer Agency
Vancouver British Columbia, V5Z 1, Canada More Info
Contact
855-569-6305
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Centre Leon Berard
Lyon , 69008, France More Info
Contact
855-569-6305
Klinikum rechts der Isar de Technischen Universitaet Muenchen
München , 81675, Germany
Universitaetsklinikum Tuebingen
Tuebingen , 72076, Germany More Info
Contact
855-569-6305
Aichi Cancer Center Hospital
Nagoya Aichi, 464-8, Japan More Info
Contact
855-569-6305
National Cancer Center Hospital
Chuo Ku Tokyo, 104-0, Japan More Info
Contact
855-569-6305
National Cancer Center Hospital East
Chiba , 277-8, Japan More Info
Contact
855-569-6305
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan More Info
Contact
855-569-6305
Asan Medical Center
Songpa-gu Seoul, 05505, Korea, Republic of More Info
Contact
855-569-6305
Seoul National University Hospital
Seoul , 03080, Korea, Republic of More Info
Contact
855-569-6305
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of More Info
Contact
855-569-6305
Samsung Medical Center
Seoul , 06351, Korea, Republic of More Info
Contact
855-569-6305
Erasmus MC
Rotterdam , 3015 , Netherlands
Haukeland University
Bergen , 5021, Norway
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain More Info
Contact
855-569-6305
South Texas Accelerated Research Therapeutics (START) Madrid
Madrid , 28050, Spain
Hospital Universitario Marques de Valdecilla
Santander , 39008, Spain
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

180

Study ID:

NCT05614739

Recruitment Status:

Recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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