FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3
NCT ID: NCT05614739
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
535 participants
INTERVENTIONAL
2023-01-12
2027-06-30
Brief Summary
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Detailed Description
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Phase 1b will include 6 dose expansion cohorts to evaluate the efficacy and safety of LOXO-435 as monotherapy or in combinations with pembrolizumab with or without enfortumab vedotin.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a: Cohort A1 LOXO-435 Monotherapy Dose Escalation
LOXO-435 administered orally
LOXO-435
Oral
Phase 1a: Cohort A2 LOXO-435 Monotherapy Dose Optimization
LOXO-435 administered orally
LOXO-435
Oral
Phase 1b: Cohort B1, B2, B4, and C1 LOXO-435 Monotherapy Dose Expansion
LOXO-435 administered orally
LOXO-435
Oral
Phase 1b: Cohort B3 LOXO-435 Plus Pembrolizumab
LOXO-435 administered orally in combination with pembrolizumab administered intravenously (IV)
LOXO-435
Oral
Pembrolizumab
IV
Phase 1b: Cohort B5 LOXO-435 Plus Pembrolizumab Plus Enfortumab Vedotin
LOXO-435 administered orally in combination with pembrolizumab administered IV and enfortumab vedotin administered IV
LOXO-435
Oral
Pembrolizumab
IV
enfortumab vedotin
IV
Interventions
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LOXO-435
Oral
Pembrolizumab
IV
enfortumab vedotin
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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University of Arizona - Cancer Center
Tucson, Arizona, United States
City of Hope
Duarte, California, United States
University of California, Los Angeles (UCLA) - Division of Hematology-Oncology
Los Angeles, California, United States
University of California - Irvine
Orange, California, United States
University of California (UC) Davis Comprehensive Cancer Center
Sacramento, California, United States
Stanford Cancer Center
Stanford, California, United States
Advent Health
Orlando, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
Indiana University (IU) Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Johns Hopkins Kimmel Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, 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
University of North Carolina (UNC) - Chapel Hill
Chapel Hill, North Carolina, United States
University of Cincinnati Medical Center (UCMC)
Cincinnati, Ohio, United States
The Ohio State University (OSU)
Columbus, Ohio, United States
University of Oklahoma - Health Sciences Center
Oklahoma City, Oklahoma, United States
Penn Medicine Lancaster General Hospital - Ann B. Barshinger Cancer Institute
Lancaster, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
Texas Oncology, P.A
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Inova Schar Cancer Institute
Falls Church, Virginia, United States
St Vincent's Hospital
Darlinghurst, , Australia
Calvary Mater Newcastle
Hunter Region, NSW, , Australia
GenesisCare North Shore
St Leonards, , Australia
Macquarie University
Sydney, , Australia
Princess Margaret Hospital
Toronto, , Canada
British Columbia Cancer Agency
Vancouver, , Canada
Beijing Cancer hospital
Beijing, , China
Beijing Hospital
Beijing, , China
Sun Yat-Sen University- Cancer Center
Guangdong, , China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, , China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
First Affiliated Hospital of Medical College of Xian jiaotong University
Xi'an, , China
Zhejiang Provincial People's Hospital
Zhejiang, , China
Institut Bergonie
Bordeaux, , France
Centre Leon Berard
Lyon, , France
Institut Gustave Roussy
Villejuif, , France
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, , Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
München, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Rabin Medical Center, Beilinson Hospital
Petah Tikva, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
IRCCS Ospedale San Raffaele
Milan, , Italy
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Roma, , Italy
National Cancer Center Hospital East
Chiba, , Japan
Aichi Cancer Center Hospital
Nagoya, , Japan
National Cancer Center Hospital
Tokyo, , Japan
Cancer Institute Hospital of JFCR
Tokyo, , Japan
Erasmus MC
GE Rotterdam, , Netherlands
Haukeland University Hospital
Bergen, , Norway
Oslo University Hospital
Oslo, , Norway
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, , Spain
Fundacion MD Anderson International Espana
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
Madrid, , Spain
Hospital Universitario Marques De Valdecilla
Santander, , Spain
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Related Links
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A Study of LOXO-435 in Patients With Cancer With a Change in a Gene Called FGFR3
Other Identifiers
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J4G-OX-JZVA
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502755-59-00
Identifier Type: OTHER
Identifier Source: secondary_id
LOXO-FG3-22001
Identifier Type: OTHER
Identifier Source: secondary_id
18594
Identifier Type: -
Identifier Source: org_study_id