A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors
Phase 1
Completed
NCT02009449
| Condition | Melanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma |
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| Phase | Phase 1 |
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| Sponsor | Eli Lilly and Company |
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| Status | Completed |
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| Enrollment | 353 participants |
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| Interventions | Pegilodecakin, Paclitaxel or Docetaxel and Carboplatin or Cisplatin, FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil), gemcitabine/nab-paclitaxel, Capecitabine |
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| Start date | Nov 15, 2013 |
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| Completion date | Feb 19, 2019 |
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| Results posted | Jul 9, 2026 |
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Summary
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.
Number of Participants With TEAEs and SAEs Observed During the Study of Pegilodecakin
From first dose of study drug through 30 days after the last dose of study drug (Up to 63 Months) · Participants
| Part A: Pegilodecakin 0.08/0.1 mg | 4 Participants |
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| Part A: Pegilodecakin 0.2/0.25 mg | 6 Participants |
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| Part A: Pegilodecakin 0.4/0.5 mg | 6 Participants |
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| Part A: Pegilodecakin 0.8/1 mg | 6 Participants |
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| Part A: Pegilodecakin 1.6/2 mg | 116 Participants |
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| Part A: Pegilodecakin 3.2/4 mg | 5 Participants |
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Pharmacokinetic (PK): Serum Concentration of Pegilodecakin
Day 29 · nanogram per milliliter (ng/mL)
| Pegilodecakin 0.08/0.1 mg | 1.36 ± 172 nanogram per milliliter (ng/mL) |
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| Pegilodecakin 0.2/0.25 mg | 1.33 ± 59 nanogram per milliliter (ng/mL) |
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| Pegilodecakin 0.4/0.5 mg | 3.33 ± 61 nanogram per milliliter (ng/mL) |
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| Pegilodecakin 0.8/1 mg | 7.32 ± 93 nanogram per milliliter (ng/mL) |
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| Pegilodecakin 1.6/2 mg | 25.4 ± 75 nanogram per milliliter (ng/mL) |
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| Pegilodecakin 3.2/4 mg | 33.2 ± 26 nanogram per milliliter (ng/mL) |
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Open in BENITIONS
View on ClinicalTrials.gov
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