OncoMatch/Clinical Trials/NCT07114601
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Is NCT07114601 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Breast Carcinoma
Colorectal Cancer
Endometrial Cancer
Biomarker criteria
Required: GRPR positive
Must have GRPR-positive disease, defined by investigator assessment of GRPR imaging.
Required: ESR1 expression (positive)
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) expression
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: Phase 1a (Cohort A1 and A2) only; prior ¹⁷⁷Lu-PSMA-617 permitted for mCRPC
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 to >25% of 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) · Santa Monica, 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 →Frequently asked questions
Is NCT07114601 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiopharmaceutical or radioligand therapy, hemi-body or whole-body radiotherapy, external beam radiation therapy to >25% of bone marrow disqualifies patients from enrollment.
Does this trial require GRPR?
Yes, GRPR positive is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify