LY4257496 for Cancer

(OMNIRAY Trial)

Recruiting at 17 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Radiopharmaceuticals

Disqualifiers: Pancreatitis, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 36 weeks or until tumor progression

421 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY4257496 to determine its safety and effectiveness for certain advanced cancers. It targets cancers with a specific protein called GRPR, such as certain types of breast, colorectal, prostate, and endometrial cancers. The trial includes different groups; some will receive LY4257496 alone, while others will receive it alongside standard cancer treatments. Suitable candidates have GRPR-positive cancer that has spread or cannot be surgically removed. Participants must manage regular hospital visits and tests throughout the trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have HIV, you must be on a stable antiretroviral therapy regimen without changes for at least 4 weeks before starting the trial.

Is there any evidence suggesting that LY4257496 is likely to be safe for humans?

Previous studies have tested LY4257496 for human safety. As this trial is in its early stages, the main goal is to assess how well participants tolerate the treatment and identify potential side effects. Consequently, there is limited safety information from other studies.

In these early trials, participants have reported some side effects, usually mild. The treatment targets specific cancer cells and is generally considered safe, though it requires careful monitoring. Since testing is still in its early phase, the treatment's safety continues to be evaluated. More data will help determine its efficacy and safety for a broader population. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about LY4257496 because it offers a novel approach to cancer treatment. Unlike standard therapies that often target cancer cells broadly, LY4257496 is designed to act more precisely, potentially minimizing damage to healthy cells. Additionally, LY4257496 is administered intravenously, which may allow for better control over dosage and absorption compared to oral medications. This targeted mechanism and delivery method could lead to more effective outcomes with fewer side effects, sparking optimism among researchers.

What evidence suggests that LY4257496 might be an effective treatment for GRPR-positive advanced cancers?

Research has shown that LY4257496 targets a specific part of many cancer cells called the Gastrin-releasing Peptide Receptor (GRPR). This receptor is present in cancers such as breast, colorectal, prostate, and endometrial. Since GRPR is involved in cell growth, blocking it might slow or stop cancer growth. Early studies suggest that LY4257496 may interfere with signals that promote cancer cell growth. Although detailed information from human studies remains limited, the mechanism of this treatment shows promise for combating these cancers. Initial results are encouraging, but further research is needed to confirm its effectiveness. Participants in this trial will receive LY4257496 in various treatment arms, including dose escalation and optimization, as well as in combination with standard care therapies. ^{1 2 5 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with advanced breast, colorectal, prostate, or endometrial cancer that tests positive for GRPR. Participants should be able to receive standard cancer treatments and commit up to 36 weeks in the study unless their tumor worsens.

Inclusion Criteria

My cancer is one of the specified types and has been confirmed by testing.

My breast cancer's ER and HER2 status are known from my latest biopsy.

I have a tumor or bone lesion that can be measured by scans.

Exclusion Criteria

I have another cancer but it's in remission and I'm expected to live more than 2 years.

Presence of bone superscan

I have had extensive radiation therapy affecting a lot of my bone marrow.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4257496 alone or with standard of care anticancer therapy

Up to 36 weeks or until tumor progression

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY4257496

Trial Overview The trial is testing LY4257496's safety and effectiveness both alone and combined with standard cancer care therapies. It's a two-part study where participants will either get LY4257496 or they'll get it along with usual treatments.

How Is the Trial Designed?

Group I: LY4257496 Phase 1b Cohort D Experimental Treatment 1 Intervention

Tumor specific cohort will receive LY4257496

Group II: LY4257496 Phase 1b Cohort C Experimental Treatment 1 Intervention

Tumor specific cohort will receive LY4257496

Group III: LY4257496 Phase 1a Dose Optimization (Cohort A2) Experimental Treatment 1 Intervention

LY4257496 administered IV

Group IV: LY4257496 Phase 1a Dose Escalation (Cohort A1) Experimental Treatment 1 Intervention

LY4257496 administered intravenously (IV)

Group V: LY4257496 + Standard of Care Phase 1b Cohort B Experimental Treatment 2 Interventions

Tumor specific cohort will receive LY4257496 alone or with standard of care anticancer therapy(ies)

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07114601

NCT07114601 | A Study of LY4257496 in Participants With ... 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) ...

2. withpower.com withpower.com/trial/phase-1-breast-neoplasms-7-2025-51d1b

LY4257496 for Cancer (OMNIRAY Trial) 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 ...

3. cancer.gov cancer.gov/clinicaltrials/NCI-2025-06835

A Study of LY4257496 in Participants With Cancer ... 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) ...

4. prostatewarriors.com prostatewarriors.com/2025/08/20/omniray-a-phase-1-clinical-trial-for-ly4257496-for-mcrpc/

a Phase 1 Clinical Trial for LY4257496 for mCRPC The trial proposes a two-part format: phase 1a explores escalating doses to find the optimal balance between safety and effectiveness, while ...

5. msn.com msn.com/en-us/health/other/eli-lilly-s-promising-cancer-therapy-study-a-potential-game-changer/ar-AA1KYzQV

Eli Lilly's Promising Cancer Therapy Study: A Potential ... The study aims to assess the safety, tolerability, and efficacy of LY4257496, both alone and in combination with standard care therapies, in ...

6. synapse.patsnap.com synapse.patsnap.com/drug/047bce3b7f524968a9a9954b3a784955

LY-4257496 - Drug Targets, Indications, Patents A Phase 1a/b Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy ...

7. breastcancertrials.org breastcancertrials.org/bct_nation/mts/mtsResult.seam?zip=94107&searchTerm1=NCT07114601

MTS Trials - BreastCancerTrials.org Purpose: To study the safety, effects (good and bad), and anti-cancer activity of LY4257496 GRPR radiopharmaceutical with or without standard of care therapy.