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
- Diseases
- Triple-negative breast cancer, Lung cancer
- 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
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| Shanghai East Hospital, Tongji University Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Tongji Hospital Tongji Medical College of Hust Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Hospital Universitario Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Kyoto University Hospital Coordinator of this site? Confirm its status | Kyoto | Japan | Recruiting |
| Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| The University of Chicago Medical Center (UCMC) Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| The Ohio State University (OSU) Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| NEXT Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| John Theurer Cancer Center At Hackensack UMC Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Community Health Network Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Florida Cancer Specialists - Sarasota Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
| Stanford Medicine Cancer Center Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| START Mountain Region Coordinator of this site? Confirm its status | West Valley City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.