OncoMatch/Clinical Trials/NCT07114601
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Is NCT07114601 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including LY4257496 and Standard of Care Anticancer Therapies for breast neoplasms.
Treatment: LY4257496 · Standard of Care Anticancer Therapies — 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 breast, colorectal, prostate, and endometrial 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Colorectal Cancer
Endometrial Cancer
Biomarker criteria
Required: GRPR positive disease by imaging
Must have GRPR-positive disease, defined by investigator assessment of GRPR imaging.
Required: ESR1 overexpression (as defined in ASCO/CAP guidelines)
To fulfill the requirement for ER+ disease by local testing, a tumor must express the ER immunohistochemistry, as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
Required: HER2 (ERBB2) overexpression (as defined in ASCO/CAP guidelines)
HER2 status should be determined by local testing, as defined in the relevant ASCO/CAP Guidelines.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiopharmaceutical or radioligand therapy
Exception: For participants with metastatic castration-resistant prostate cancer (mCRPC), prior ¹⁷⁷Lu-PSMA-617 is permitted.
Phase 1a (Cohort A1 and A2) only: Previously received radiopharmaceutical or radioligand therapy. For participants with metastatic castration-resistant prostate cancer (mCRPC), prior ¹⁷⁷Lu-prostate-specific membrane antigen (PSMA)-617 is permitted.
Cannot have received: hemi-body or whole-body radiotherapy
Previously received any prior hemi-body or whole-body radiotherapy
Cannot have received: external beam radiation therapy
Exception: to greater than 25% of the bone marrow
prior external beam radiation therapy (EBRT) to greater than 25% of the bone marrow
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- University of California, Los Angeles (UCLA) · Los Angeles, California
- Stanford University Medical Center · Stanford, California
- Biogenix Molecular, LLC · Miami, Florida
- Moffitt · Tampa, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
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