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Official Title

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)

Phase
Phase 1
Sponsor
Eli Lilly and Company
Enrollment
421
Timeline
Aug 2025 → Apr 2035
About This Study

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. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.

Eligibility Criteria

Inclusion Criteria

  • 1Must have histologically or cytologically proven diagnosis of locally advanced, unresectable, or metastatic cancer.
  • 2Must be assessed by computed tomography (CT)/magnetic resonance imaging (MRI) to confirm at least 1 of the following:
  • 3At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • 4If 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
  • 5Must have GRPR-positive disease, defined by investigator assessment of GRPR imaging.
  • 6Must have the following histologically or cytologically confirmed diagnosis:
  • 7Estrogen receptor (ER+)/human epidermal growth factor receptor 2 (HER2-) breast cancer
  • 8ER+/HER2+ breast cancer
  • 9Colorectal carcinoma
  • 10Metastatic castration-resistant prostate cancer
  • 11Endometrial carcinoma
  • 12Other GRPR-positive solid tumor
  • 13For 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.
  • 14To 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.
  • 15HER2 status should be determined by local testing, as defined in the relevant ASCO/CAP Guidelines.
  • 16Must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1.
  • 17Must be able to comply with outpatient treatment, laboratory monitoring, imaging, and required clinic visits for the duration of trial participation.

Exclusion Criteria

  • 1Previously received any radiopharmaceutical. For participants with metastatic castration-resistant prostate cancer (mCRPC), prior 177\^Lu-prostate-specific membrane antigen (PSMA)-617 is permitted.
  • 2Has a history of ongoing acute pancreatitis within 1 year of screening.
  • 3Previously received any prior hemi-body or whole-body radiotherapy, or prior external beam radiation therapy (EBRT) to greater than 25% of the bone marrow.
  • 4A 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.
  • 5Has evidence of ongoing and untreated urinary tract obstruction or unmanageable urinary incontinence.
  • 6Has known active hepatitis B virus (HBV) (screening for HBV is not required for individuals who do not have a history of HBV, unless required by local regulations). Individuals with treated/chronic HBV are eligible for the trial provided they meet the following criteria:
  • 7Individuals with positive hepatitis B surface antigen (HBsAg) must be on permitted suppressive antiviral therapy prior to C1D1, remain on the same antiviral treatment throughout trial, and should follow local standards for continuation of therapy after completion of trial therapy.
  • 8Undetectable HBV deoxyribonucleic acid (DNA) less than or equal to 28 days of C1D1.
  • 9Has known active hepatitis C virus (HCV) (screening for HCV is not required for individuals who do not have a history of HCV unless required by local regulations). Individuals previously treated for HCV are eligible for the trial provided they meet the following criteria:
  • 10Completion of curative antiviral therapy.
  • 11HCV viral load below the limit of quantification less than or equal to 28 days of C1D1.
  • 12Negative hepatitis C antibody result OR, if positive, then must be hepatitis C RNA negative.
  • 13Has known untreated human immunodeficiency virus (HIV) infection (screening for HIV is not required unless required by local regulations). Participants on permitted antiretroviral therapy (ART) and who have well-controlled HIV infection/disease are eligible provided they meet the following criteria:
  • 14Must be on a stable and permitted ART regimen without changes in drug or dose, for at least 4 weeks prior to C1D1 and have a viral load of \<400 copies per mL prior to less than or equal to 28 days of C1D1.
  • 15CD4+ T-cell count greater than or equal to 350 cells/uL less than or equal to 28 days of C1D1.
  • 16Has an active second malignancy unless in remission with life expectancy greater than 2 years.
  • 17Has known hypersensitivity to any component or excipient of LY4257496.

Locations

21 sites participating in this study

Emory University School of Medicine - Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

City of Hope

Duarte, California 91010

Recruiting

University of California, Los Angeles (UCLA)

Los Angeles, California 90025

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →