Actively Recruiting
FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3
Led by Eli Lilly and Company · Updated on 2026-05-12
535
Participants Needed
84
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a solid tumor cancer with an FGFR3 pathway alteration identified by molecular testing that is considered actionable
- Cohort A1: Have an alteration in FGFR3 or its ligands
- Cohort A2, B2, B3, and B5: Have a diagnosis of locally advanced or metastatic urothelial cancer with a qualifying FGFR3 genetic alteration
- Cohorts B1 and B4: Have a diagnosis of locally advanced or metastatic urothelial cancer
- Cohort C1: Have a diagnosis of locally advanced or metastatic non-urothelial solid tumor malignancy with a qualifying FGFR3 genetic alteration
- Have measurable or non-measurable disease as defined by RECIST v1.1 for Cohorts A1 and B3
- Have measurable disease as defined by RECIST v1.1 for Cohorts A2, B1, B2, B4, B5, and C1
- Have an adequate tumor tissue sample available or be considered upon review if unavailable
- Have an ECOG performance status of 0 or 1 for Cohorts A1, A2, B3, and B5; 0 to 2 for Cohorts B1, B2, B4, and C1
- For Cohort A1/C1: Have received all standard therapies or be unwilling or have no standard therapy available; no limit on prior therapies
- For Cohorts A2, B2, B3: Have received at least one prior regimen for locally advanced or metastatic disease
- For Cohorts B1 and B4: Have received at least two prior regimens for locally advanced or metastatic disease
- Cohort B5: Have not received prior systemic therapy for locally advanced or metastatic urothelial cancer
- For Cohorts A1/A2/B3: Prior FGFR inhibitor treatment allowed but not required
- For Cohorts B1/B4: Must have been treated previously with erdafitinib
- For Cohorts B2, B5, and C1: Must be FGFR inhibitor naive
You will not qualify if you...
- Have primary central nervous system malignancy
- Have untreated or uncontrolled central nervous system metastases
- Have current corneal keratopathy or retinal disorder (asymptomatic ophthalmic conditions may be eligible)
- Have any serious unresolved side effects from previous therapy
- Have significant cardiovascular disease
- Have prolonged QT interval corrected for heart rate using Fridericia's formula
- Have active uncontrolled infection or other serious medical conditions
- Are pregnant, lactating, or planning to breastfeed during the study or within 6 months after last dose (those who stopped breastfeeding may enroll)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 84 locations
1
University of Arizona - Cancer Center
Tucson, Arizona, United States, 85719
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
University of California, Los Angeles (UCLA) - Division of Hematology-Oncology
Los Angeles, California, United States, 90095
Actively Recruiting
4
University of California - Irvine
Orange, California, United States, 92868
Actively Recruiting
5
University of California (UC) Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
6
Stanford Medicine Cancer Center
Stanford, California, United States, 94305
Actively Recruiting
7
Advent Health
Orlando, Florida, United States, 32804
Actively Recruiting
8
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
9
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States, 60637
Actively Recruiting
10
Indiana University (IU) Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
11
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
12
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Actively Recruiting
13
Johns Hopkins Kimmel Cancer Center
Baltimore, Maryland, United States, 21231-2410
Actively Recruiting
14
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
15
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
16
Washington University in St. Louis
St Louis, Missouri, United States, 63108
Actively Recruiting
17
New York University (NYU)
New York, New York, United States, 10016
Actively Recruiting
18
Weill Cornell Medicine
New York, New York, United States, 10021
Not Yet Recruiting
19
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
20
Columbia University
New York, New York, United States, 10032
Actively Recruiting
21
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
22
University of Rochester - Wilmot Cancer Institute
Rochester, New York, United States, 14642
Actively Recruiting
23
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
24
University of North Carolina (UNC) - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
25
University of Cincinnati Medical Center (UCMC)
Cincinnati, Ohio, United States, 45267
Actively Recruiting
26
The Ohio State University (OSU)
Columbus, Ohio, United States, 43210
Actively Recruiting
27
University of Oklahoma - Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
28
Penn Medicine Lancaster General Hospital - Ann B. Barshinger Cancer Institute
Lancaster, Pennsylvania, United States, 17601
Actively Recruiting
29
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
30
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
31
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
32
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
33
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
34
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
35
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
36
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
37
University of Texas Southwestern
Dallas, Texas, United States, 75244
Actively Recruiting
38
Texas Oncology, P.A
Dallas, Texas, United States, 75251
Actively Recruiting
39
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
40
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
41
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
42
Inova Schar Cancer Institute
Falls Church, Virginia, United States, 22042
Not Yet Recruiting
43
St Vincent's Hospital
Darlinghurst, Australia, NSW 2010
Actively Recruiting
44
Calvary Mater Newcastle
Hunter Region, NSW, Australia, 2310
Actively Recruiting
45
GenesisCare North Shore
St Leonards, Australia, 2065
Actively Recruiting
46
Macquarie University
Sydney, Australia, 2109
Actively Recruiting
47
Princess Margaret Hospital
Toronto, Canada, M5G 2M9
Actively Recruiting
48
British Columbia Cancer Agency
Vancouver, Canada, V5Z 1J3
Actively Recruiting
49
Beijing Cancer hospital
Beijing, China, 100142
Actively Recruiting
50
Beijing Hospital
Beijing, China, 100730
Actively Recruiting
51
Sun Yat-Sen University- Cancer Center
Guangdong, China, 510060
Actively Recruiting
52
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China, 310002
Actively Recruiting
53
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China, 200000
Actively Recruiting
54
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China, 300060
Actively Recruiting
55
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China, 710061
Actively Recruiting
56
Zhejiang Provincial People's Hospital
Zhejiang, China, 310003
Actively Recruiting
57
Institut Bergonie
Bordeaux, France, 33076
Actively Recruiting
58
Centre Leon Berard
Lyon, France, 69373
Actively Recruiting
59
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
60
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, Germany, 23538
Not Yet Recruiting
61
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
München, Germany, 81675
Actively Recruiting
62
Universitaetsklinikum Tuebingen
Tübingen, Germany, 72016
Actively Recruiting
63
Rabin Medical Center, Beilinson Hospital
Petah Tikva, Israel, 49100
Actively Recruiting
64
Sheba Medical Center
Tel Litwinsky, Israel, 5265601
Actively Recruiting
65
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
66
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Roma, Italy, 00168
Actively Recruiting
67
National Cancer Center Hospital East
Chiba, Japan, 277-8577
Actively Recruiting
68
Aichi Cancer Center Hospital
Nagoya, Japan, 464-8681
Actively Recruiting
69
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Actively Recruiting
70
Cancer Institute Hospital of JFCR
Tokyo, Japan, 135-8550
Actively Recruiting
71
Erasmus MC
GE Rotterdam, Netherlands, 3015
Actively Recruiting
72
Haukeland University Hospital
Bergen, Norway, 5021
Actively Recruiting
73
Oslo University Hospital
Oslo, Norway, 0450
Actively Recruiting
74
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
75
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
76
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
77
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
78
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, Spain, 08908
Actively Recruiting
79
Fundacion MD Anderson International Espana
Madrid, Spain, 28033
Actively Recruiting
80
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
81
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
Madrid, Spain, 28050
Actively Recruiting
82
Hospital Universitario Marques De Valdecilla
Santander, Spain, 39008
Actively Recruiting
83
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
84
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2SB
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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