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Recruiting Phase 1 NCT07114601

A Study of LY4257496 in Participants With Cancer (OMNIRAY)

Trial Parameters

Condition Breast Neoplasms
Sponsor Eli Lilly and Company
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 421
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-08-06
Completion 2030-04
Interventions
LY4257496Standard of Care Anticancer TherapiesLY4257529

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Must have histologically or cytologically proven diagnosis of locally advanced, unresectable, or metastatic cancer. * Must be assessed by computed tomography (CT)/magnetic resonance imaging (MRI) to confirm at least 1 of the following: * At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * If only bone lesions are present without a soft-tissue component, a bone scan or MRI must confirm at least 2 detectable lesions considered to represent active metastases * Must have GRPR-positive disease, defined by investigator assessment of GRPR imaging. * Must have the following histologically or cytologically confirmed diagnosis: * Estrogen receptor (ER+)/human epidermal growth factor receptor 2 (HER2-) breast cancer * ER+/HER2+ breast cancer * Colorectal carcinoma * Metastatic castration-resistant prostate cancer * Endometrial carcinoma. Carcinosarcoma is eligible. Uterine leiomyosarcoma, adenosarcoma, or endometrial stromal s

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