A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors
This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.
Checked against the public recordLast updated Jul 9, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Eli Lilly and Company
- Interventions being studied
- Drug: Pegilodecakin; Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin; Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil); Drug: gemcitabine/nab-paclitaxel; Drug: Capecitabine; Drug: Pazopanib; Drug: Pembrolizumab; Drug: Paclitaxel; Drug: nivolumab; Drug: Gemcitabine/carboplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: Part A Escalation Cohorts: o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts: * Tumors with all histological diagnosis or tissue origin may be enrolled * Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease. * Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC) * At least 18 years of age * Performance Status of 0 or 1 * Adequate organ function Exclusion Criteria: * Hematologic malignancies * Pregnant or lactating * Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders * Myocardial infarction within the last 6 months * Unstable angina, or unstable cardiac arrhythmia requiring medication * Surgery within the last 28 days * Systemic fungal, bacterial, viral, or other infection * History of bleeding diathesis within the last 6 months * Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCLA Medical Hematology & OncologyLos Angeles, California
- UCSFSan Francisco, California
- Sarah Cannon Research Institute at HealthONEDenver, Colorado
- Florida Cancer Specialists & Research InstituteSarasota, Florida
- Dana Farber Cancer InstituteBoston, Massachusetts
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Stephenson Cancer Center at Oklahoma University TSET Phase 1 ProgramOklahoma City, Oklahoma
- Sarah Cannon Research InstituteNashville, Tennessee
- The University of Texas M.D. Anderson Cancer CenterHouston, Texas
- South Texas Accelerated Research TherapeuticsSan Antonio, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 9, 2026. Always confirm current availability with the study team.