A Study of LY4175408 in Participants With Advanced Cancer

Launched by ELI LILLY AND COMPANY · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called LY4175408 to see if it is safe and helpful for people with certain advanced cancers, including types of lung cancer, endometrial (uterine) cancer, and a specific form of breast cancer called triple-negative breast cancer. The goal is to understand how the medicine works in the body, how long it stays in the bloodstream, and whether it can help control the cancer.

People who might be able to join this study are adults with advanced or spreading cancer who have already tried all standard treatments available, or who have chosen not to continue with standard treatments, or for whom no standard treatments exist. Participants need to be in generally good health aside from their cancer, and must not have certain serious health problems like uncontrolled infections, heart issues, or lung diseases. If they join, they may be in the study for up to four years, during which doctors will carefully monitor their response to the medicine and any side effects. It’s important to note that this study is not yet open for enrollment.

Gender

ALL

Eligibility criteria

• 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; 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:
• • 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).
• • 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.