New treatment option for Carcinoma, Non-Small-Cell Lung
Official title A Study of LY4175408 in Participants With Advanced Cancer
ClinicalTrials.gov ID: NCT07046923
What this study is testing
What is LY4175408?
LY4175408 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for carcinoma, non-small-cell lung.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Prior treatment with a protein tyrosine kinase 7 (PTK7) antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as payload (prior therapy with...
- 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)
See the full eligibility 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Orlando, Florida, United States
- Sarasota, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
- Chengdu, China
- Shanghai, China
- Wuhan, China
- Lyon, France
- Villejuif, France
- Kyoto, Japan
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; Orlando, Florida, United States; Sarasota, Florida, United States; Chicago, Illinois, United States; Indianapolis, Indiana, United States; Boston, Massachusetts, United States and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.