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Clinical Trial Summary

The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. 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.


Clinical Trial Description

This is a Phase 1a/1b multicenter, open-label study in participants with advanced or metastatic solid tumor malignancies known to express Nectin 4. This study is comprised of two phases: Dose Escalation and Dose Optimization (1a), and Dose expansion (1b). Phase 1a will assess the safety, tolerability, and pharmacokinetics of LY4052031 to determine the recommended phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety of LY4052031 at the RP2D/optimal dose in expansion cohorts based on tumor type and/or treatment history. ;


Study Design


Related Conditions & MeSH terms

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

NCT number NCT06465069
Study type Interventional
Source Eli Lilly and Company
Contact Patient Advocacy
Phone 855-569-6305
Email clinicaltrials@loxooncology.com
Status Not yet recruiting
Phase Phase 1
Start date June 2024
Completion date May 2027

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