A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors

Фаза 1 Завершено NCT02009449

Заболевание	Melanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma
Фаза	Фаза 1
Спонсор	Eli Lilly and Company
Статус	Завершено
Участники	353 участн.
Вмешательство	Pegilodecakin, Paclitaxel or Docetaxel and Carboplatin or Cisplatin, FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil), gemcitabine/nab-paclitaxel, Capecitabine
Дата начала	15.11.2013
Дата завершения	19.02.2019
Публикация результатов	9.07.2026

Кратко

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
Part A: Pegilodecakin 0.2/0.25 mg	6 Participants
Part A: Pegilodecakin 0.4/0.5 mg	6 Participants
Part A: Pegilodecakin 0.8/1 mg	6 Participants
Part A: Pegilodecakin 1.6/2 mg	116 Participants
Part A: Pegilodecakin 3.2/4 mg	5 Participants

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)
Pegilodecakin 0.2/0.25 mg	1.33 ± 59 nanogram per milliliter (ng/mL)
Pegilodecakin 0.4/0.5 mg	3.33 ± 61 nanogram per milliliter (ng/mL)
Pegilodecakin 0.8/1 mg	7.32 ± 93 nanogram per milliliter (ng/mL)
Pegilodecakin 1.6/2 mg	25.4 ± 75 nanogram per milliliter (ng/mL)
Pegilodecakin 3.2/4 mg	33.2 ± 26 nanogram per milliliter (ng/mL)

Открыть в BENITIONS Открыть на ClinicalTrials.gov

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Все исследования

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