Comparing 5 approaches for breast neoplasms
Official title: A Study of LY4257496 in Participants With Cancer (OMNIRAY)
A Phase 1a/b Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults With GRPR-Positive Advanced Solid Tumors (OMNIRAY)
Interventions
LY4257496
Administered IV
Standard of Care Anticancer Therapies
Fulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, Abemaciclib
LY4257529
Administered IV at select sites
Canadian Sites (4)
Juravinski Cancer Centre
Hamilton, Canada
Lady Davis Institute for Medical Research Jewish General Hospital
Montreal, Canada
Sunnybrook Health Sciences Centre
Toronto, Canada
Princess Margaret Hospital
Toronto, Canada
Eligibility Criteria
See who this study is looking for41 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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 (CohortsCohortA group of participants sharing a characteristic, followed together.Read more → A1 dose escalationDose escalationLater groups receive higher amounts than earlier ones, increased step by step.Read more → 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
- −Has known hypersensitivity to any component or excipient of LY4257496.
- −Have known active hepatitis B virus (HBV). Exception: Individuals with chronic HBV if they:
- −Have undetectable HBV DNA ≤14 days of C1D1.
- −Have known active hepatitis C virus (HCV). Exception: Individuals previously treated for HCV if they:
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −Have untreated human immunodeficiency virus (HIV) infection. Exception: Individuals who have well-controlled HIV infection/disease and they:
- −Phase 1a (CohortCohortA group of participants sharing a characteristic, followed together.Read more → 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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −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 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.
- −Completed curative antiviral therapy.
- −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.
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is investigating how something functions in the body, rather than testing a treatment directly.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
What is being given or done in this study: LY4257496, Standard of CareStandard of careThe treatment normally given for a condition outside a study.Read more → Anticancer Therapies, LY4257529.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There are 5 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 421 people.
The study is currently expected to finish around April 2035.
The main measurement is taken over: From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Phase 1a Dose EscalationDose escalationLater groups receive higher amounts than earlier ones, increased step by step.Read more →: Maximum Tolerated DoseMaximum tolerated doseThe highest amount that can be given before side effects become unacceptable.Read more → of LY4257496 — measured over From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days.
Phase 1a Dose Optimization: Number of Dose Limiting Toxicities of LY4257496 — measured over From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days.
Phase 1b Dose Expansion and Optimization: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) — measured over From C1D1 through efficacy follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →, estimated as Week 42. Cycle = 42 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07114601 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About LY4257496Drug
Administered IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Standard of Care Anticancer TherapiesDrug
Fulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, Abemaciclib
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About LY4257529Diagnostic test
Administered IV at select sites
From the trial registry — its own words, unedited.
What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days.
The study as a whole is currently expected to finish around 2035-04.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 421 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Hamilton, Canada; Montreal, Canada; Toronto, Canada; Detroit, Michigan, United States; Grand Rapids, Michigan, United States; New York, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This 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 therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric 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.
Other Sites (4)
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
BAMF Health Inc.
Grand Rapids, Michigan, United States
New York University (NYU) Langone Medical Center
New York, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.