LY4175408 for selected advanced lung, endometrial, and triple‑negative breast cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial of LY4175408 that measures safety, preliminary anti‑tumor activity, and how the drug is processed in the body. The study uses dose‑optimization and dose‑expansion cohorts to find appropriate dosing and to observe responses in selected tumor types. Participants may have measurable disease per RECIST v1.1 for certain cohorts and must have ECOG performance status of 0 or 1. Participation and follow‑up could last up to four years and the study excludes patients previously treated with PTK7‑targeting antibody therapies.

Why it matters

Who can join: the full rules

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 (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

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). Prior topoisomerase I-based ADCs are not allowed in cohorts A2, B1 or B2.
* 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.

Where it's running

• Stanford Medicine Cancer Center
  Stanford, California, United States Recruiting
• Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
  Orlando, Florida, United States Recruiting
• Florida Cancer Specialists - Sarasota
  Sarasota, Florida, United States Recruiting
• The University of Chicago Medical Center (UCMC)
  Chicago, Illinois, United States Recruiting
• Community Health Network
  Indianapolis, Indiana, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.