A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Part of paid clinical trials in Duarte, California.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT06465069
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Advanced Solid Tumor
- Bladder Cancer
- Cervical Cancer
- Esophageal Cancer
- Head and Neck Squamous Cell Carcinoma
- Metastatic Solid Tumor
- Non-small Cell Lung Cancer
- Ovarian Cancer
- Pancreatic Cancer
- Prostate Cancer
- Recurrent Solid Tumor
- Renal Pelvis Cancer
- Triple Negative Breast Cancer
- Urinary Bladder Neoplasm
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- LY4052031 — DRUGIntravenous
Study Details
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.
Key Dates
- First listed
- Jun 18, 2024
- Start date
- Jul 1, 2024
- Status verified
- Aug 2026
- Primary completion
- May 31, 2027
- Completion
- May 31, 2027
Study Design
- Enrollment
- 420 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: LY4052031 (Dose-escalation, Cohort A1)Escalating doses of LY4052031 administered intravenously (IV).
- Experimental: LY4052031 (Dose-optimization, Cohort A2)Comparing 2 or more doses (evaluated during dose escalation) of LY4052031 administered IV.
- Experimental: LY4052031 (Dose-expansion, Cohort B1, B2, C1)LY4052031 administered IV.
Primary Outcome Measure
Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031 [ Time Frame: Cycle 1 (21 Days) ]
Central Contacts
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
- Physicians interested in becoming principal investigators please contact
Locations (22)
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City of Hope National Medical Center· Duarte, CAUniversity of California, San Diego (UCSD) - Moores Cancer Center· La Jolla, CAUCLA Department of Medicine-Hematology/Oncology· Los Angeles, CASarah Cannon Research Institute at HealthOne· Denver, COFlorida Cancer Specialists and Research Institute· St. Petersburg, FLUniversity of Chicago Hospital· Chicago, IL
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