Home › Trials › NCT07046923

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

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

Phase 1 Interventional Eli Lilly and Company · NCT07046923

This trial tests an experimental drug called LY4175408 to see if it is safe and works for people with advanced or metastatic non‑small cell or small cell lung cancer, endometrial cancer, or triple‑negative breast cancer.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations25 sites (Stanford, California and 24 other locations)
Trial IDNCT07046923 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced or metastatic NSCLC, SCLC, endometrial cancer, or triple‑negative breast cancer who have completed or are not candidates for standard therapies, have ECOG ≤1, and (for certain cohorts) measurable disease per RECIST v1.1.

Not a fit: Patients who have poor performance status (ECOG >1), who can still receive effective standard therapies, or who previously received PTK7‑targeting antibody treatments are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, LY4175408 could provide a new targeted treatment option that shrinks tumors or slows progression in these advanced cancers.

How similar studies have performed: PTK7‑targeted therapies are a relatively new approach with limited clinical data so far, with only early‑phase signals reported but no definitive large‑scale successes yet.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Stanford, California and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaEndometrial NeoplasmsNeoplasm MetastasisTriple Negative Breast Cancer
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.