Actively Recruiting
FORAGER-1: Phase 1 Open-Label Study of LOXO-435 in Locally Advanced or Metastatic Solid Tumors Including Urothelial Cancer With FGFR3 Alterations
Led by Eli Lilly and Company · Updated on 2026-05-19
535
Participants Needed
82
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, side effects, and effectiveness of LOXO-435 alone or combined with other standard cancer medicines in people with advanced solid tumors that have changes in the FGFR3 gene. This includes cancers of the urinary system like urothelial cancer. This open-label, multi-center phase 1 study aims to find the best dose and evaluate how well LOXO-435 works, with participation lasting up to 2.5 years or longer if the cancer does not worsen. The study has two main phases: Phase 1a, which focuses on dose escalation and optimization of LOXO-435 given orally, and Phase 1b, which expands the dose evaluation. LOXO-435 is studied as monotherapy or combined with pembrolizumab (an intravenous drug) with or without enfortumab vedotin (also given intravenously). Different groups receive these treatments to assess safety and early effectiveness in treating FGFR3-altered cancers. Participants will have regular assessments including tumor measurements, safety checks, and monitoring for side effects over the course of the study. Researchers will collect data on treatment response, progression, survival, physical function, and bladder-related symptoms. The study also monitors drug levels in the body and tracks adverse events for up to about 30 months, ensuring close follow-up throughout the trial.
CONDITIONS
Brief 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 solid tumor cancer with an FGFR3 gene alteration confirmed by molecular testing
- Histological diagnosis of locally advanced or metastatic urothelial cancer for certain study groups
- Must have measurable disease as defined by standard criteria for most cohorts
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for some groups, and up to 2 for others
- Prior systemic therapies as defined per cohort, including previous FGFR inhibitor treatment status
- Adequate tumor tissue sample availability or review for enrollment
- Participants must be 18 years or older
You will not qualify if you...
- Primary central nervous system (CNS) malignancy
- Untreated or uncontrolled CNS metastases
- Current corneal keratopathy or retinal disorder, except asymptomatic conditions
- Serious unresolved side effects from prior treatments
- Significant cardiovascular disease
- QT interval prolongation corrected for heart rate
- Active uncontrolled infection or other serious medical conditions
- Pregnancy, breastfeeding, or planning to breastfeed during the study or within 6 months after last dose
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 30 months or 2.5 years
Participants receive LOXO-435 as an oral drug, alone or in combination with pembrolizumab and/or enfortumab vedotin administered intravenously, to assess safety, tolerability, and preliminary anti-tumor activity.
Visits occur regularly during treatment cycles, including initial dose escalation and optimization phases followed by dose expansion cohorts.
Trial Site Locations
Total: 82 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
St Vincent's Hospital
Darlinghurst, Australia, NSW 2010
Actively Recruiting
43
Calvary Mater Newcastle
Hunter Region, NSW, Australia, 2310
Actively Recruiting
44
GenesisCare North Shore
St Leonards, Australia, 2065
Actively Recruiting
45
Macquarie University
Sydney, Australia, 2109
Actively Recruiting
46
Princess Margaret Hospital
Toronto, Canada, M5G 2M9
Actively Recruiting
47
British Columbia Cancer Agency
Vancouver, Canada, V5Z 1J3
Actively Recruiting
48
Beijing Cancer hospital
Beijing, China, 100142
Actively Recruiting
49
Beijing Hospital
Beijing, China, 100730
Actively Recruiting
50
Sun Yat-Sen University- Cancer Center
Guangdong, China, 510060
Actively Recruiting
51
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China, 310002
Actively Recruiting
52
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China, 200000
Actively Recruiting
53
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China, 300060
Actively Recruiting
54
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China, 710061
Actively Recruiting
55
Zhejiang Provincial People's Hospital
Zhejiang, China, 310003
Actively Recruiting
56
Institut Bergonie
Bordeaux, France, 33076
Actively Recruiting
57
Centre Leon Berard
Lyon, France, 69373
Actively Recruiting
58
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
59
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
München, Germany, 81675
Actively Recruiting
60
Universitaetsklinikum Tuebingen
Tübingen, Germany, 72016
Actively Recruiting
61
Rabin Medical Center, Beilinson Hospital
Petah Tikva, Israel, 49100
Actively Recruiting
62
Sheba Medical Center
Tel Litwinsky, Israel, 5265601
Actively Recruiting
63
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
64
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Roma, Italy, 00168
Actively Recruiting
65
National Cancer Center Hospital East
Chiba, Japan, 277-8577
Actively Recruiting
66
Aichi Cancer Center Hospital
Nagoya, Japan, 464-8681
Actively Recruiting
67
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Actively Recruiting
68
Cancer Institute Hospital of JFCR
Tokyo, Japan, 135-8550
Actively Recruiting
69
Erasmus MC
GE Rotterdam, Netherlands, 3015
Actively Recruiting
70
Haukeland University Hospital
Bergen, Norway, 5021
Actively Recruiting
71
Oslo University Hospital
Oslo, Norway, 0450
Actively Recruiting
72
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
73
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
74
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
75
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
76
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, Spain, 08908
Actively Recruiting
77
Fundacion MD Anderson International Espana
Madrid, Spain, 28033
Actively Recruiting
78
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
79
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
Madrid, Spain, 28050
Actively Recruiting
80
Hospital Universitario Marques De Valdecilla
Santander, Spain, 39008
Actively Recruiting
81
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
82
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
P
Physicians interested in becoming principal investigators please 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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