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Clinical Trials in China / NCT06238479
Active, not recruiting Phase 1

A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors

NCT06238479 · tracked via the Priya Life Science China tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1
Started
2024-03-05
Last updated
2026-05-22

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)

LY4101174

LY4101174: Intravenous

Study summary

The purpose of this study is to find out whether the study drug, LY4101174, is safe, tolerable and effective in participants with select advanced or metastatic solid tumors. The study is conducted in two parts - phase 1a (dose-escalation, dose-optimization) and phase 1b (dose-expansion). The study will last up to approximately 4 years. Eligible patients will have the option to continue taking study drug after the study is complete.

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 C1: triple negative breast cancer * Cohort C2: non-small cell lung cancer * Cohort C3: ovarian or fallopian tube cancer * Cohort C4: cervical cancer * Cohort C5: head and neck squamous cell carcinoma * Prior Systemic Therapy Criteria: * Cohort A1/C1-5: 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/C1-5: 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) * Cohorts A2, B1, B2, C1-5: measurable disease required 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 history of corneal transplant * Any serious unresolved toxicities from prior therapy * Significant cardiovascular disease * Current of history of intestinal obstruction in the previous 3 months * Recent thromboembolic event and/or clinically significant bleeding * 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 * Individual with active uncontrolled infection

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
AdventHealth Orlando Orlando Florida
Emory University Atlanta Georgia
Massachusetts General Hospital Boston Massachusetts
Washington University School of Medicine St Louis Missouri
Perlmutter Cancer Center at NYU Langone Hospital - Long Island Mineola New York
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health New York New York
Memorial Sloan Kettering Cancer Center New York New York
UT Southwestern Medical Center Dallas Texas
South Texas Accelerated Research Therapeutics (START) San Antonio Texas
Austin Health Heidelberg Australia
Icon Cancer Centre Kurralta Park Kurralta Park Australia
Institut Jules Bordet Anderlecht Belgium
Peking University First Hospital Beijing China
Hunan Cancer Hospital Changsha China
Shanghai East Hospital Shanghai China
Centre Oscar Lambret Lille France
Centre Leon Berard Lyon France
Institut Paoli-Calmettes Marseille France
CHU Strasbourg-Hautepierre Strasbourg France
Gustave Roussy Villejuif France
National Cancer Center Hospital Chūōku Japan
National Cancer Center Hospital East Kashiwa Japan
The Cancer Institute Hospital of JFCR Kōtō City Japan
Kyoto University Hospital Kyoto Japan
Hospital Universitari Vall d'Hebron Barcelona Spain
MD Anderson Cancer Center Madrid Spain
Hospital Universitario 12 de Octubre Madrid Spain
Hospital Universitario Virgen Del Rocio Seville Spain

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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 NCT06238479 on ClinicalTrials.gov ↗ ← All trials in China