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Clinical Trials in China / NCT06465069
Recruiting Phase 1

A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

NCT06465069 · tracked via the Priya Life Science China tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1
Started
2024-07-01
Last updated
2026-09-04

Condition(s) studied

Metastatic Solid TumorRecurrent Solid TumorAdvanced Solid TumorUrinary Bladder NeoplasmTriple Negative Breast CancerNon-small Cell Lung CancerEsophageal CancerPancreatic CancerOvarian CancerCervical CancerHead and Neck Squamous Cell CarcinomaProstate CancerRenal Pelvis CancerBladder Cancer

Investigational drug(s) / intervention(s)

LY4052031

LY4052031: 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Have one of the following solid tumor cancers: * Cohort A1: 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 * Cohort A2/B1/B2: urothelial carcinoma * Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer * Prior Systemic Therapy Criteria: * Cohort A1/C: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies * Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies. * Prior enfortumab vedotin specific requirements: * Cohorts A1/A2/C: prior treatment with enfortumab vedotin is allowed, but not required * Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting * Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting. * Measurability of disease * Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1) * Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1 * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations Exclusion Criteria: * Individual with known or suspected uncontrolled CNS metastases * Individual with uncontrolled hypercalcemia * Individual with uncontrolled diabetes * Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant * Any serious unresolved toxicities from prior therapy * Significant cardiovascular disease * Recent thromboembolic event and/or clinically significant bleeding disorder * Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms * History of pneumonitis/interstitial lung disease * History of Grade ≥3 skin toxicity when receiving enfortumab vedotin * Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
City of Hope National Medical Center Duarte California Recruiting
University of California, San Diego (UCSD) - Moores Cancer Center La Jolla California Not Yet 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
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
NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute) New York New York Not Yet 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

More Eli Lilly and Company trials in China

Other trials for the same condition

Official registry record

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 China