Actively Recruiting
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Led by Eli Lilly and Company · Updated on 2026-05-12
420
Participants Needed
31
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.
CONDITIONS
Official Title
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have one of the following solid tumor cancers: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma, or prostate cancer
- For Cohort A1 and C: have received all standard therapies or no standard therapy is available; no limit on number of prior therapies
- For Cohorts A2, B1, B2: have received at least one prior treatment in advanced or metastatic setting; no limit on number of prior therapies
- Prior treatment with enfortumab vedotin allowed for Cohorts A1, A2, C; must be enfortumab vedotin naive for Cohort B1; must have received enfortumab vedotin for Cohort B2
- Have measurable disease as defined by RECIST v1.1 (Cohort A1 may include non-measurable disease)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have adequate archival tumor tissue or be willing to undergo a screening biopsy per regulations
You will not qualify if you...
- Known or suspected uncontrolled central nervous system metastases
- Uncontrolled high blood calcium (hypercalcemia)
- Uncontrolled diabetes
- Evidence of corneal keratopathy or keratitis, or history of corneal transplant
- Serious unresolved side effects from prior therapy
- Significant cardiovascular disease
- Recent blood clotting event or significant bleeding disorder
- Prolonged QTc interval of 470 ms or more
- History of pneumonitis or interstitial lung disease
- History of Grade 3 or higher skin toxicity with enfortumab vedotin
- Pregnancy, breastfeeding, or planning to breastfeed during the study or within 30 days after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010-0269
Actively Recruiting
2
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, United States, 80218
Actively Recruiting
3
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida, United States, 33705
Not Yet Recruiting
4
University of Chicago Hospital
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
START Midwest Cancer and Hematology Centers of W Michigan
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
7
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029-6574
Actively Recruiting
9
Columbia University Irving Medical Center
New York, New York, United States, 10032-3729
Actively Recruiting
10
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
11
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
12
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4000
Actively Recruiting
13
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229
Actively Recruiting
14
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
15
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
16
St Vincent's Hospital
Darlinghurst, Australia, 2010
Actively Recruiting
17
Linear Clinical Research
Nedlands, Australia, 6009
Actively Recruiting
18
Beijing Cancer hospital
Beijing, China, 100142
Actively Recruiting
19
Sun Yat-sen University Cancer Center
Guangzhou, China, 510060
Actively Recruiting
20
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China, 200000
Not Yet Recruiting
21
Institut Gustave Roussy (Igr)
Villejuif, France, 94805
Actively Recruiting
22
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
23
The Cancer Institute Hospital of JFCR
Kōtō City, Japan, 135-8550
Actively Recruiting
24
Aichi Cancer Center Hospital
Nagoya, Japan, 464-8681
Actively Recruiting
25
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
26
Catalan Institute of Oncology Duran i Reynals Hospital
Barcelona, Spain, 8908
Actively Recruiting
27
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
28
Hospital Madrid Norte Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
29
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
30
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Actively Recruiting
31
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
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
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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