A Study of LY4175408 in Participants With Advanced Cancer

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1a Dose Escalation (Cohort A1) 		Escalating doses of LY4175408 administered intravenously (IV)
  • Drug: LY4175408
    IV infusion
Experimental
Phase 1a Dose Optimization (Cohort A2) 		Two or more doses of LY4175408 (evaluated during dose escalation) administered IV
  • Drug: LY4175408
    IV infusion
Experimental
Phase 1b Dose Expansion (Cohort B) 		LY4175408 administered IV
  • Drug: LY4175408
    IV infusion

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

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