A Study of LY4175408 in Participants With Advanced Cancer
NCT ID: NCT07046923
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
240 participants
INTERVENTIONAL
2025-07-28
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a Dose Escalation (Cohort A1)
Escalating doses of LY4175408 administered intravenously (IV)
LY4175408
IV infusion
Phase 1a Dose Optimization (Cohort A2)
Two or more doses of LY4175408 (evaluated during dose escalation) administered IV
LY4175408
IV infusion
Phase 1b Dose Expansion (Cohort B)
LY4175408 administered IV
LY4175408
IV infusion
Interventions
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LY4175408
IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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; 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 ≤1.
* For dose optimization/dose and expansion cohorts (Cohort A2, Cohort B): Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Stanford Cancer Center
Stanford, California, United States
Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
Orlando, Florida, United States
Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
Community Health Network
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
John Theurer Cancer Center At Hackensack UMC
Hackensack, New Jersey, United States
Columbia University
New York, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University (OSU) Wexner Medical Center
Columbus, Ohio, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
START Mountain Region
West Valley City, Utah, United States
NEXT Virginia
Fairfax, Virginia, United States
Centre Leon Berard
Lyon, , France
Institut Gustave Roussy
Villejuif, , France
Kyoto University Hospital
Kyoto, , Japan
National Cancer Center Hospital
Tokyo, , Japan
Cancer Institute Hospital of JFCR
Tokyo, , Japan
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Related Links
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A Study of LY4175408 in Participants With Advanced Cancer
Other Identifiers
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J6D-MC-JSDA
Identifier Type: OTHER
Identifier Source: secondary_id
2025-521916-20-00
Identifier Type: CTIS
Identifier Source: secondary_id
27401
Identifier Type: -
Identifier Source: org_study_id