Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 16, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT06465069). This is a study registration, not published results. Lead sponsor: Eli Lilly and Company. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 460 participants (ESTIMATED). 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: DRUG: LY4052031; DRUG: Pembrolizumab. Primary outcome measures: Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031 , Cycle 1 (21 Days); Phase 1b: To assess the antitumor activity of LY4052031 as monotherapy or in combination with pembrolizumab: Overall response rate (ORR) , Up to Approximately 48 Months or 4 Years. Brief 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.