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

1상 완료 NCT02009449

대상 질환	Melanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma
임상 단계	1상
스폰서	Eli Lilly and Company
상태	완료
참여자 수	353 명
중재(약물)	Pegilodecakin, Paclitaxel or Docetaxel and Carboplatin or Cisplatin, FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil), gemcitabine/nab-paclitaxel, Capecitabine
시작일	2013년 11월 15일
완료일	2019년 2월 19일
결과 공개일	2026년 7월 9일

요약

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)

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

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전체 임상

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