A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors

Description

The purpose of this study is to find out whether the study drug, LY4101174, is safe, tolerable and effective in participants with select advanced or metastatic solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

Conditions

Metastatic Solid Tumor, Recurrent Solid Tumor, Advanced Solid Tumor, Urinary Bladder Neoplasm, Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Esophageal Cancer, Pancreatic Cancer, Ovarian Cancer, Cervical Cancer, Head and Neck Squamous Cell Carcinoma, Prostate Cancer, Renal Pelvis Cancer, Bladder Cancer

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Study Overview

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Study Details

Study overview

The purpose of this study is to find out whether the study drug, LY4101174, is safe, tolerable and effective in participants with select advanced or metastatic solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid Tumors

A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors

Condition
Metastatic Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Orlando

Advent Health Orlando Hospital, Orlando, Florida, United States, 32804

Orlando

Advent Health Orlando, Orlando, Florida, United States, 32804

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

New York

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States, 10016

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Dallas

UT Southwestern Medical Center, Dallas, Texas, United States, 75390-8884

San Antonio

South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, United States, 78229-3307

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have one of the following solid tumor cancers:
  • * Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer
  • * Cohort A2/B1/B2: urothelial carcinoma
  • * Cohort C1: triple negative breast cancer
  • * Cohort C2: non-small cell lung cancer
  • * Cohort C3: ovarian or fallopian tube cancer
  • * Cohort C4: cervical cancer
  • * Cohort C5: head and neck squamous cell carcinoma
  • * Prior Systemic Therapy Criteria:
  • * Cohort A1/C1-5: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies
  • * Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.
  • * Prior enfortumab vedotin specific requirements:
  • * Cohorts A1/A2/C1-5: prior treatment with enfortumab vedotin is allowed, but not required
  • * Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting
  • * Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.
  • * Measurability of disease
  • * Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
  • * Cohorts A2, B1, B2, C1-5: measurable disease required as defined by RECIST v1.1
  • * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • * Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations
  • * Individual with known or suspected uncontrolled CNS metastases
  • * Individual with uncontrolled hypercalcemia
  • * Individual with uncontrolled diabetes
  • * Individual with evidence of corneal keratopathy or history of corneal transplant
  • * Any serious unresolved toxicities from prior therapy
  • * Significant cardiovascular disease
  • * Current of history of intestinal obstruction in the previous 3 months
  • * Recent thromboembolic event or bleeding disorder
  • * Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms
  • * History of pneumonitis/interstitial lung disease
  • * History of Grade ≥3 skin toxicity when receiving enfortumab vedotin
  • * Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
  • * Individual with active uncontrolled infection

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2027-03-04