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NCT07046923RecruitingPhase 1

A Study of LY4175408 in Participants With Advanced Cancer

A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors

Source: ClinicalTrials.gov · Last updated 23 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
240 (estimated)
First submitted
24 Jun 2025
Start date
28 Jul 2025
Primary completion date
Jul 2030
Lead sponsor
Eli Lilly and Company
NCT number
NCT07046923
EU CT number
2025-521916-20-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 240
  • From 28 Jul 2025 to the primary completion date, Jul 2030
  • 27 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.
  • History of pneumonitis/interstitial lung disease.

Lab values

  • Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 milliseconds (ms)

Other

  • Individuals who are pregnant, breastfeeding, or plan to breastfeed during the trial or within 30 days of the last dose of trial intervention.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
West China Hospital,Sichuan University
Coordinator of this site? Confirm its status
ChengduChinaNot yet recruiting
Shanghai East Hospital, Tongji University
Coordinator of this site? Confirm its status
ShanghaiChinaNot yet recruiting
Tongji Hospital Tongji Medical College of Hust
Coordinator of this site? Confirm its status
WuhanChinaNot yet recruiting
Hospital Universitario Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
Kyoto University Hospital
Coordinator of this site? Confirm its status
KyotoJapanRecruiting
Cancer Institute Hospital of JFCR
Coordinator of this site? Confirm its status
TokyoJapanRecruiting
National Cancer Center Hospital
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TokyoJapanRecruiting
Severance Hospital, Yonsei University Health System
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Massachusetts General Hospital
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BostonUnited StatesRecruiting
The University of Chicago Medical Center (UCMC)
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ChicagoUnited StatesRecruiting
The Ohio State University (OSU) Wexner Medical Center
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ColumbusUnited StatesRecruiting
NEXT Virginia
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FairfaxUnited StatesRecruiting
John Theurer Cancer Center At Hackensack UMC
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HackensackUnited StatesRecruiting
MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
Community Health Network
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IndianapolisUnited StatesRecruiting
Sarah Cannon Research Institute
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Columbia University
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
Florida Cancer Specialists - Sarasota
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SarasotaUnited StatesRecruiting
Stanford Medicine Cancer Center
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StanfordUnited StatesRecruiting
Washington University
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
START Mountain Region
Coordinator of this site? Confirm its status
West Valley CityUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.