Trials / Recruiting
RecruitingNCT06465069
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 420 (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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 evaluates an antibody-drug conjugate that binds to the protein nectin-4, which is expressed on certain cancer cells, delivering the drug to the cancer. 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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LY4052031 | Intravenous |
Timeline
- Start date
- 2024-07-01
- Primary completion
- 2027-05-01
- Completion
- 2027-05-01
- First posted
- 2024-06-18
- Last updated
- 2026-03-24
Locations
28 sites across 8 countries: United States, Australia, China, France, Japan, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06465069. Inclusion in this directory is not an endorsement.