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)
Eli Lilly and Company
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 asse…
Interventions
- DrugLY4257496
Administered IV
- DrugStandard of Care Anticancer Therapies
Fulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, Abemaciclib
- Diagnostic TestLY4257529
Administered IV at select sites
Locations (28)
- City of HopeDuarte, California
- University of California, Los Angeles (UCLA)Santa Monica, California
- Stanford University Medical CenterStanford, California
- Biogenix Molecular, LLCMiami, Florida
- MoffittTampa, Florida
- Emory University School of Medicine - Winship Cancer InstituteAtlanta, Georgia