A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
LY4052031: Intravenous
Pembrolizumab: Intravenous
Study summary
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.
Eligibility
Primary outcome measure(s)
- Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031 — Cycle 1 (21 Days)
Number of participants with dose-limiting toxicities (DLTs) - Phase 1b: To assess the antitumor activity of LY4052031 as monotherapy or in combination with pembrolizumab: Overall response rate (ORR) — Up to Approximately 48 Months or 4 Years
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Trial sites (39)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | Recruiting |
| University of California, San Diego (UCSD) - Moores Cancer Center | La Jolla | California | Recruiting |
| UCLA Department of Medicine-Hematology/Oncology | Los Angeles | California | Recruiting |
| Sarah Cannon Research Institute at HealthOne | Denver | Colorado | Recruiting |
| Florida Cancer Specialists and Research Institute | St. Petersburg | Florida | Completed |
| Emory University | Atlanta | Georgia | Recruiting |
| University of Chicago Hospital | Chicago | Illinois | Recruiting |
| IU Simon Cancer Center | Indianapolis | Indiana | Not Yet Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| START Midwest Cancer and Hematology Centers of W Michigan | Grand Rapids | Michigan | Recruiting |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | Recruiting |
| NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute) | New York | New York | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | Recruiting |
| Columbia University Irving Medical Center | New York | New York | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Recruiting |
| Sarah Cannon Research Institute | Nashville | Tennessee | Recruiting |
| Tennessee Oncology PLLC | Nashville | Tennessee | Not Yet Recruiting |
| University of Texas MD Anderson Cancer Center | Houston | Texas | Recruiting |
| South Texas Accelerated Research Therapeutics (START) | San Antonio | Texas | Recruiting |
| University of Utah - Huntsman Cancer Institute | Salt Lake City | Utah | Recruiting |
| START Mountain Region | West Valley City | Utah | Recruiting |
| St Vincent's Hospital | Darlinghurst | Australia | Recruiting |
| Linear Clinical Research | Nedlands | Australia | Recruiting |
| Beijing Cancer hospital | Beijing | China | Recruiting |
| Sun Yat-sen University Cancer Center | Guangzhou | China | Recruiting |
| Renji Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | China | Recruiting |
| Institut Gustave Roussy (Igr) | Villejuif | France | Recruiting |
| National Cancer Center Hospital | Chūōku | Japan | Recruiting |
| National Cancer Center Hospital East | Kashiwa, Chiba | Japan | Recruiting |
| The Cancer Institute Hospital of JFCR | Kōtō City | Japan | Recruiting |
| Aichi Cancer Center Hospital | Nagoya | Japan | Recruiting |
| Asan Medical Center | Seoul | South Korea | Recruiting |
| Catalan Institute of Oncology Duran i Reynals Hospital | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
| Hospital Madrid Norte Sanchinarro | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen Del Rocio | Seville | Spain | Recruiting |
| St Bartholomew's Hospital | London | United Kingdom | Recruiting |
| The Christie NHS Foundation Trust | Manchester | United Kingdom | Recruiting |
On this site
📄 Keytruda (pembrolizumab) drug profile →More Eli Lilly and Company trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06465069 on ClinicalTrials.gov ↗ ← All trials in the UK