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New radiation drug targets Hard-to-Treat cancers

NCT ID NCT07114601

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 8 times

Summary

This study tests a new drug, LY4257496, that delivers radiation directly to cancer cells with a specific protein (GRPR). It is for adults with advanced solid tumors like breast, prostate, or colorectal cancer that have not responded to other treatments. The goal is to see if the drug is safe, tolerable, and effective at shrinking tumors. Participants will receive the drug alone or with standard care, and the study lasts up to 36 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 421 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Apr 2035

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * Esophageal squamous cell carcinoma * Adenocarcinoma of the stomach, gastroesophageal junction, or esophagus * Colorectal carcinoma * Metastatic castration-resistant prostate cancer * Endometrial carcinoma. Carcinosarcoma is eligible. Uterine leiomyosarcoma, adenosarcoma, or endometrial stromal sarcoma is not eligible. * Low-grade papillary serous ovarian cancer * Other non-Central Nervous System (CNS) primary GRPR-positive solid tumors (Cohorts A1 dose escalation and D1 dose expansion only) * For participants with breast cancer diagnosis, where possible, ER and HER2 status should be assessed from the most recent tissue biopsy taken at the time of presentation with recurrent or metastatic disease. * 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. * HER2 status should be determined by local testing, as defined in the relevant ASCO/CAP Guidelines. * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1. * Must be able to comply with outpatient treatment, laboratory monitoring, imaging, and required clinic visits for the duration of trial participation. Exclusion Criteria: * Phase 1a (Cohort A1 and A2) only: Previously received radiopharmaceutical or radioligand therapy. For participants with prostate cancer, prior ¹⁷⁷Lu-prostate-specific membrane antigen (PSMA) is permitted. * Has a history of ongoing acute pancreatitis within 1 year of screening. * Previously received any prior hemi-body or whole-body radiotherapy, or prior external beam radiation therapy (EBRT) to greater than 25% of the bone marrow. * A bone superscan, defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity. * Has evidence of ongoing and untreated urinary tract obstruction or unmanageable urinary incontinence. * Have known active hepatitis B virus (HBV). Exception: Individuals with chronic HBV if they: * Have positive HBsAg * Are on suppressive antiviral therapy, as allowed per local regulations prior to C1D1 * Remain on the same antiviral treatment throughout study, and should follow local standards for continuation of therapy after completion of trial therapy. * Have undetectable HBV DNA ≤14 days of C1D1. * Have known active hepatitis C virus (HCV). Exception: Individuals previously treated for HCV if they: * Completed curative antiviral therapy. * Have an HCV viral load below the limit of quantification ≤14 days of C1D1 and. * Are positive for anti-HCV antibodies and negative for HCV ribonucleic acid (RNA) before randomization. * Have untreated human immunodeficiency virus (HIV) infection. Exception: Individuals who have well-controlled HIV infection/disease and they: * Are on a stable and permitted antiretroviral therapy (ART) regimen without changes in drug or dose, for at least 4 weeks prior to C1D1 * Have a viral load of \<400 copies/mL ≤14 days of C1D1. * Have a CD4+ T-cell count ≥350 cells/mL ≤14 days of C1D1. * Have not had an opportunistic infection within the past 12 months. * Has an active second malignancy unless in remission with life expectancy greater than 2 years. * Has known hypersensitivity to any component or excipient of LY4257496.

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Conditions

The condition(s) this trial relates to.

borderline ovarian serous tumor breast neoplasm castration-resistant prostate carcinoma colorectal carcinoma colorectal neoplasm endometrial carcinoma endometrium neoplasm esophageal adenocarcinoma Esophageal Neoplasms esophageal squamous cell carcinoma estrogen-receptor positive breast cancer gastric adenocarcinoma gastric neoplasm gastroesophageal junction adenocarcinoma hormone receptor-positive breast cancer metastatic neoplasm metastatic prostate carcinoma Neoplasm Metastasis neoplasm of esophagus ovarian serous adenocarcinoma prostate cancer prostate neoplasm triple-positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasms Colorectal neoplasms Endometrial neoplasms Esophageal neoplasms Neoplasm metastasis Prostate neoplasm Stomach neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    32 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BAMF Health Inc.

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Barbara Ann Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Biogenix Molecular, LLC

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33165, United States

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Emory University School of Medicine - Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Hospital Universitari Quiron Dexeus Barcelona

    NOT_YET_RECRUITING

    Barcelona, 08028, Spain

  • Institut Curie

    NOT_YET_RECRUITING

    Paris, 75005, France

  • Institut de Cancerologie de l'Ouest - site St-Herblain

    NOT_YET_RECRUITING

    Saint-Herblain, 44805, France

  • Juravinski Cancer Centre

    RECRUITING

    Hamilton, L8V 5C2, Canada

  • Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)

    NOT_YET_RECRUITING

    München, 81675, Germany

  • Kyoto University Hospital

    NOT_YET_RECRUITING

    Kyoto, 606-8507, Japan

  • LMU Klinikum Muenchen-Campus Grosshadern

    NOT_YET_RECRUITING

    München, 80336, Germany

  • Lady Davis Institute for Medical Research Jewish General Hospital

    NOT_YET_RECRUITING

    Montreal, H3T 1E2, Canada

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114, United States

  • Moffitt

    RECRUITING

    Tampa, Florida, 33612, United States

  • National Cancer Center Hospital East

    NOT_YET_RECRUITING

    Chiba, 277-8577, Japan

  • New York University (NYU) Langone Medical Center

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

  • Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

    NOT_YET_RECRUITING

    Beijing, 100730, China

  • Princess Margaret Hospital

    RECRUITING

    Toronto, M5G 2M9, Canada

  • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz

    NOT_YET_RECRUITING

    Madrid, 28040, Spain

  • Stanford University Medical Center

    RECRUITING

    Stanford, California, 94305, United States

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, M4N 3M5, Canada

  • Texas Oncology - DFW (Sammons CC)

    NOT_YET_RECRUITING

    Dallas, Texas, 75246, United States

  • The University of Osaka Hospital

    NOT_YET_RECRUITING

    Osaka, 565-0871, Japan

  • Tianjin Cancer Hospital Airport Hospital

    NOT_YET_RECRUITING

    Tianjin, 300060, China

  • Universitaetsklinikum Erlangen

    NOT_YET_RECRUITING

    Erlangen, 91054, Germany

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, 45147, Germany

  • University of California, Los Angeles (UCLA)

    RECRUITING

    Santa Monica, California, 90404, United States

  • University of Pittsburgh Medical Center

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.