A Study of LY4175408 in Participants With Advanced Cancer

Not Applicable

Not yet recruiting

• Conditions: Neoplasm Metastasis; Triple Negative Breast Cancer; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Endometrial Neoplasms

• Registration Number: NCT07046923
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-24
• Study First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Study Start: 2025-07-01
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-02
• Primary Completion: 2030-07
• Study Completion: 2030-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Phase 1a-Number of Participants with Dose Limiting Toxicities of LY4175408	1 Cycle (21 days)
Phase 1b-Overall Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)	Baseline up to approximately 4 years	Per investigator assessed Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

Secondary Outcome Measures

Name	Time	Method
Phase 1a and 1b-Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of LY4175408 (total antibody, conjugated antibody, free payload)	First 4 cycles (84 days)
Phase 1a-ORR: Percentage of Participants with Best Response of CR or PR	Baseline up to approximately 4 years	Per investigator assessed RECIST 1.1
Phase 1a and 1b-Time to Response (TTR)	Baseline up to approximately 4 years	Per investigator assessed RECIST 1.1
Phase 1a and 1b-Progression-free Survival (PFS)	Baseline up to approximately 4 years	Per investigator assessed RECIST 1.1
Phase 1a and 1b-PK: Area under the Concentration versus Time Curve (AUC) of LY4175408 (total antibody, conjugated antibody, free payload)	First 4 cycles (84 days)
Phase 1a and 1b-Disease Control Rate (DCR)	Baseline up to approximately 4 years	Per investigator assessed RECIST 1.1
Phase 1a and 1b-Duration of Response (DOR)	Baseline up to approximately 4 years	Per investigator assessed RECIST 1.1

Trial Locations

Locations (21)

Stanford Cancer Center; 🇺🇸 Stanford, California, United States

Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute; 🇺🇸 Orlando, Florida, United States

Florida Cancer Specialists - Sarasota; 🇺🇸 Sarasota, Florida, United States

The University of Chicago Medical Center (UCMC); 🇺🇸 Chicago, Illinois, United States

Community Health Network; 🇺🇸 Indianapolis, Indiana, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

John Theurer Cancer Center At Hackensack UMC; 🇺🇸 Hackensack, New Jersey, United States

Columbia University; 🇺🇸 New York, New York, United States

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

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