A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
NCT Number: NCT06465069
Acronym: NEXUS-01
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
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
Sponsor: Eli Lilly and Company
Collaborators: Loxo Oncology, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-05
Locations: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|START Midwest, Grand Rapids, Michigan, 49546, United States|South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, 78229-3307, United States

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.

Primary Outcome Measures: Phase 1a: To determine the recommended phase 2 dose (RP2D) or optimal dose of LY4052031, Number of participants with dose-limiting toxicities (DLTs), Cycle 1 (21 Days)|Phase 1b: To assess the antitumor activity of LY4052031 Monotherapy: Overall response rate (ORR), ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), Up to Approximately 48 Months or 4 Years]
Secondary Outcome Measures: To characterize the pharmacokinetics (PK) properties of LY4052031: Minimum Plasma Concentration (Cmin), PK: Cmin of LY4052031, Cycle 1 (21 Days)|To characterize the PK properties of LY4052031: Area under the concentration versus time curve (AUC), PK: AUC of LY4052031, Cycle 1 (21 Days)|To evaluate the preliminary antitumor activity of LY4052031: Overall response rate (ORR), ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)), Up to Approximately 48 Months or 4 Years|To evaluate the preliminary antitumor activity of LY4052031: Duration of response (DOR), DOR per investigator assessed RECIST 1.1, Up to Approximately 48 Months or 4 Years|To evaluate the preliminary antitumor activity of LY4052031: Time to response (TTR), TTR per investigator assessed RECIST 1.1, Up to Approximately 48 Months or 4 Years|To evaluate the preliminary antitumor activity of LY4052031: Progression free survival (PFS), PFS per investigator assessed RECIST 1.1, Up to Approximately 48 Months or 4 Years|To evaluate the preliminary antitumor activity of LY4052031: Disease control rate (DCR), DCR per investigator assessed RECIST 1.1, Up to Approximately 48 Months or 4 Years|To evaluate the preliminary antitumor activity of LY4052031: Overall survival (OS), OS per investigator assessed RECIST 1.1, Up to Approximately 48 Months or 4 Years