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

第1相完了 NCT02009449

対象疾患	Melanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma
相	第1相
スポンサー	Eli Lilly and Company
ステータス	完了
参加者数	353 名
介入（薬剤）	Pegilodecakin, Paclitaxel or Docetaxel and Carboplatin or Cisplatin, FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil), gemcitabine/nab-paclitaxel, Capecitabine
開始日	2013年11月15日
完了日	2019年2月19日
結果公開日	2026年7月9日

概要

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 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)

BENITIONS で見る ClinicalTrials.gov の原文を見る

同じ疾患の他の治験

Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroqu — Massachusetts General Hospital
Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tum — National Cancer Institute (NCI)
XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer — XBiotech, Inc.
Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanc — National Cancer Institute (NCI)
Testing the Addition of an Anti-cancer Drug, Elimusertib (BAY 1895344) ATR Inhibitor, to t — National Cancer Institute (NCI)
Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poo — ECOG-ACRIN Cancer Research Group

すべての治験

このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。

English 한국어 日本語中文 Русский