RECRUITING

FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

FORAGER-1: A Phase 1, Open-Label, Multicenter Study of LOXO-435 (LY3866288) in Locally Advanced or Metastatic Solid Tumors Including Urothelial Cancer With FGFR3 Alterations

Quick Facts

Study Start:2023-01-12
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05614739

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have solid tumor cancer with an FGFR3 pathway alteration on molecular testing in tumor or blood sample that is deemed as actionable
  2. * Cohort A1: Presence of an alteration in FGFR3 or its ligands
  3. * Cohort A2, B2, B3, and B5: Histological diagnosis of urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration
  4. * Cohorts B1 and B4: Histological diagnosis of urothelial cancer that is locally advanced or metastatic
  5. * 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
  6. * Measurability of disease:
  7. * Cohort A1 and B3: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v1.1)
  8. * Cohorts A2, B1, B2, B4, B5, and C1: Measurable disease required as defined by RECIST v1.1
  9. * Have adequate tumor tissue sample available. Participants with inadequate tissue sample availability may still be considered for enrollment upon review
  10. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for Cohorts A1, A2, B3, and B5
  11. * Less than or equal to 2 for Cohorts B1, B2, B4, and C1
  12. * Prior Systemic Therapy Criteria:
  13. * 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.
  14. * 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
  15. * There is no restriction on number of prior therapies
  16. * Cohort B5: Participants have not received prior systemic therapy for locally advanced or metastatic UC
  17. * FGFR inhibitor specific requirements:
  18. * Cohort A1/A2/B3: Prior FGFR inhibitor treatment is permitted but not required
  19. * Cohort B1/B4: Participants must have been previously treated with erdafitinib
  20. * Cohort B2, B5, and C1: Participants must be FGFR inhibitor naïve
  1. * Participants with primary central nervous system (CNS) malignancy
  2. * Untreated or uncontrolled CNS metastases
  3. * Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible
  4. * Any serious unresolved toxicities from prior therapy
  5. * Significant cardiovascular disease
  6. * Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF)
  7. * Active uncontrolled systemic infection or other clinically significant medical conditions
  8. * 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

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
13176154559
clinical_inquiry_hub@lilly.com

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States
UCLA Department of Medicine-Hematology/Oncology
Santa Monica, California, 90095
United States
Advent Health Hematology and Oncology
Celebration, Florida, 34747
United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
United States
The University of Chicago Medical Center
Chicago, Illinois, 60637
United States
SKCCC at Johns Hopkins
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital
Boston, Massachusetts, 02144
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7305
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Penn Medicine: University of Pennsylvania Health System/Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37204
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-12
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-01-12
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • Bladder Cancer
  • Bladder Urothelial Carcinoma
  • Urinary Bladder Cancer
  • Urinary Tract Cancer
  • Renal Pelvis Cancer
  • Ureter Cancer

Additional Relevant MeSH Terms

  • Urinary Bladder Neoplasms
  • Neoplasm Metastasis
  • Ureteral Neoplasms