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Clinical Trials in Japan / NCT07046923
Recruiting Phase 1

A Study of LY4175408 in Participants With Advanced Cancer

NCT07046923 · tracked via the Priya Life Science Japan tracker
Phase
Phase 1
Started
2025-07-28
Last updated
2026-06-23

Condition(s) studied

Carcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaEndometrial NeoplasmsNeoplasm MetastasisTriple Negative Breast Cancer

Investigational drug(s) / intervention(s)

LY4175408Pembrolizumab →Carboplatin →Cisplatin →

LY4175408: IV infusion

Pembrolizumab: IV infusion

Carboplatin: IV infusion

Cisplatin: IV infusion

Study summary

The purpose of this study is to measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this study will evaluate how much LY4175408 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. Participation could last up to 4 years.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Have one of the following advanced or metastatic solid tumor cancers: * Non-small cell lung cancer (NSCLC) * Small cell lung cancer (SCLC) * Endometrial cancer * Triple negative breast cancer (TNBC) (characterized by HR-negative disease and HER2-negative expression according to American Society of Clinical Oncology (ASCO) - College of American Pathologists guidelines). * Received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating investigator (except in Cohort B1 and B2 expansion, which require participants who are treatment naive in the advanced metastatic setting); OR the individual is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease. * Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to (≤) 1. * For dose optimization/dose and expansion cohorts (Cohort A2, Cohort B/C): Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Cohorts B1/B2: NSCLC with no known actionable genomic alterations. ≤2 prior lines of systemic therapy for advanced or metastatic disease in safety lead-in; no prior systemic therapy in expansion Exclusion Criteria: * Prior treatment with a protein tyrosine kinase 7 (PTK7) antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as payload (prior therapy with a PTK7 ADC with a non-topoisomerase I inhibitor payload OR non-PTK7 ADC with any payload is permitted). Prior topoisomerase I-based ADCs are not allowed in cohorts A2, B1 or B2. * Any serious unresolved toxicities from prior therapy. * Individual with known or suspected history of uncontrolled central nervous system (CNS) metastases. * Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection. * Significant cardiovascular disease. * Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 milliseconds (ms) * History of pneumonitis/interstitial lung disease. * Individuals who are pregnant, breastfeeding, or plan to breastfeed during the trial or within 30 days of the last dose of trial intervention.

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
Stanford Medicine Cancer Center Stanford California Recruiting
Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute Orlando Florida Recruiting
Florida Cancer Specialists - Sarasota Sarasota Florida Recruiting
The University of Chicago Medical Center (UCMC) Chicago Illinois Recruiting
Community Health Network Indianapolis Indiana Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Washington University St Louis Missouri Recruiting
John Theurer Cancer Center At Hackensack UMC Hackensack New Jersey Recruiting
Columbia University New York New York Recruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center New York New York Recruiting
The Ohio State University (OSU) Wexner Medical Center Columbus Ohio Recruiting
Sarah Cannon Research Institute Nashville Tennessee Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
START Mountain Region West Valley City Utah Recruiting
NEXT Virginia Fairfax Virginia Recruiting
West China Hospital, Sichuan University Chengdu China Not Yet Recruiting
Shanghai East Hospital, Tongji University Shanghai China Not Yet Recruiting
Tongji Hospital - Tongji Medical College of HUST Wuhan China Not Yet Recruiting
Centre Leon Berard Lyon France Recruiting
Institut Gustave Roussy Villejuif France Recruiting
Kyoto University Hospital Kyoto Japan Recruiting
National Cancer Center Hospital Tokyo Japan Recruiting
Cancer Institute Hospital of JFCR Tokyo Japan Recruiting
Severance Hospital, Yonsei University Health System Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Hospital Universitario Vall d'Hebron Barcelona Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting

On this site

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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 NCT07046923 on ClinicalTrials.gov ↗ ← All trials in Japan