A Study of LY4257496 in Participants With Cancer (OMNIRAY)

Part of paid clinical trials in Duarte, California.

Sponsor
Eli Lilly and Company
Study ID
NCT07114601
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • LY4257496 — DRUG
    Administered IV
  • Standard of Care Anticancer Therapies — DRUG
    Fulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, Abemaciclib
  • LY4257529 — DIAGNOSTIC_TEST
    Administered IV at select sites

Study Details

The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.

Key Dates

Start date
Aug 6, 2025
Status verified
Jun 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2035

Study Design

Enrollment
421 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: LY4257496 Phase 1a Dose Escalation (Cohort A1)
    LY4257496 administered intravenously (IV)
  • Experimental: LY4257496 Phase 1a Dose Optimization (Cohort A2)
    LY4257496 administered IV
  • Experimental: LY4257496 + Standard of Care Phase 1b Cohort B
    Tumor specific cohort will receive LY4257496 alone or with standard of care anticancer therapy(ies)
  • Experimental: LY4257496 Phase 1b Cohort C
    Tumor specific cohort will receive LY4257496
  • Experimental: LY4257496 Phase 1b Cohort D
    Tumor specific cohort will receive LY4257496

Primary Outcome Measure

Phase 1a Dose Escalation: Maximum Tolerated Dose of LY4257496 [ Time Frame: From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 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 (16)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
University of California, Los Angeles (UCLA)Santa MonicaCalifornia90404-
Stanford University Medical CenterStanfordCalifornia94305-
Biogenix Molecular, LLCMiamiFlorida33165-
MoffittTampaFlorida33612-
Emory University School of Medicine - Winship Cancer InstituteAtlantaGeorgia30322-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
BAMF Health Inc.Grand RapidsMichigan49503-
Washington UniversitySt LouisMissouri63110-
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
New York University (NYU) Langone Medical CenterNew YorkNew York10016-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Texas Oncology - DFW (Sammons CC)DallasTexas75246-
MD Anderson Cancer CenterHoustonTexas77030-

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City of Hope· Duarte, CAUniversity of California, Los Angeles (UCLA)· Santa Monica, CAStanford University Medical Center· Stanford, CABiogenix Molecular, LLC· Miami, FLMoffitt· Tampa, FLEmory University School of Medicine - Winship Cancer Institute· Atlanta, GA

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