Trials / Active Not Recruiting
Active Not RecruitingNCT06238479
A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors
A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 490 (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, 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.
Detailed description
This is a Phase 1a/1b multicenter, open-label study in participants with select advanced or metastatic solid tumors. 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 LY4101174 to determine the recommended phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety of LY4101174 at the RP2D/optimal dose in 7 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 | LY4101174 | Intravenous |
Timeline
- Start date
- 2024-03-05
- Primary completion
- 2027-03-01
- Completion
- 2027-03-01
- First posted
- 2024-02-02
- Last updated
- 2026-04-13
Locations
28 sites across 7 countries: United States, Australia, Belgium, China, France, Japan, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06238479. Inclusion in this directory is not an endorsement.