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
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Start date
Jul 1, 2024
Status verified
May 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) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (17)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-0269-
UCLA Department of Medicine-Hematology/OncologyLos AngelesCalifornia90024-
Sarah Cannon Research Institute at HealthOneDenverColorado80218-
Florida Cancer Specialists and Research InstituteSt. PetersburgFlorida33705-
University of Chicago HospitalChicagoIllinois60637-
IU Simon Cancer CenterIndianapolisIndiana46202-
Massachusetts General HospitalBostonMassachusetts02215-
START Midwest Cancer and Hematology Centers of W MichiganGrand RapidsMichigan49546-
Washington University School of Medicine in St. LouisSt LouisMissouri63110-
Columbia University Irving Medical CenterNew YorkNew York10032-3729-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-6574-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Sarah Cannon Research InstituteNashvilleTennessee37203-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-4000-
South Texas Accelerated Research Therapeutics (START)San AntonioTexas78229-
University of Utah - Huntsman Cancer InstituteSalt Lake CityUtah84112-
START Mountain RegionWest Valley CityUtah84119-

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