BENITIONSClinical Trial Intelligence

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

1期 已完成 NCT02009449

适应症Melanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma
分期1期
申办方Eli Lilly and Company
状态已完成
受试者人数353 人
干预(药物)Pegilodecakin, Paclitaxel or Docetaxel and Carboplatin or Cisplatin, FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil), gemcitabine/nab-paclitaxel, Capecitabine
开始日期2013年11月15日
完成日期2019年2月19日
结果公布日2026年7月9日

摘要

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 mg4 Participants
Part A: Pegilodecakin 0.2/0.25 mg6 Participants
Part A: Pegilodecakin 0.4/0.5 mg6 Participants
Part A: Pegilodecakin 0.8/1 mg6 Participants
Part A: Pegilodecakin 1.6/2 mg116 Participants
Part A: Pegilodecakin 3.2/4 mg5 Participants

Pharmacokinetic (PK): Serum Concentration of Pegilodecakin

Day 29 · nanogram per milliliter (ng/mL)

Pegilodecakin 0.08/0.1 mg1.36 ± 172 nanogram per milliliter (ng/mL)
Pegilodecakin 0.2/0.25 mg1.33 ± 59 nanogram per milliliter (ng/mL)
Pegilodecakin 0.4/0.5 mg3.33 ± 61 nanogram per milliliter (ng/mL)
Pegilodecakin 0.8/1 mg7.32 ± 93 nanogram per milliliter (ng/mL)
Pegilodecakin 1.6/2 mg25.4 ± 75 nanogram per milliliter (ng/mL)
Pegilodecakin 3.2/4 mg33.2 ± 26 nanogram per milliliter (ng/mL)

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。