NCT02009449 — drugset

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.

Timeline

Start: 2013-11-15
Primary completion: 2019-02-19
Completion: 2023-07-22

Publications

Naing A, Wong DJ, Infante JR, Korn WM, Aljumaily R, Papadopoulos KP, Autio KA, Pant S, Bauer TM, Drakaki A, Daver NG, Hung A, Ratti N, McCauley S, Van Vlasselaer P, Verma R, Ferry D, Oft M, Diab A, Garon EB, Tannir NM. Pegilodecakin combined with pembrolizumab or nivolumab for patients with advanced solid tumours (IVY): a multicentre, multicohort, open-label, phase 1b trial. Lancet Oncol. 2019 Nov;20(11):1544-1555. doi: 10.1016/S1470-2045(19)30514-5. Epub 2019 Sep 25.
Naing A, Papadopoulos KP, Autio KA, Ott PA, Patel MR, Wong DJ, Falchook GS, Pant S, Whiteside M, Rasco DR, Mumm JB, Chan IH, Bendell JC, Bauer TM, Colen RR, Hong DS, Van Vlasselaer P, Tannir NM, Oft M, Infante JR. Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human Interleukin-10 (AM0010) in Patients With Advanced Solid Tumors. J Clin Oncol. 2016 Oct 10;34(29):3562-3569. doi: 10.1200/JCO.2016.68.1106.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Pegilodecakin	Protein / enzyme biologic	10 ug/kg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	20 ug/kg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	0.08 mg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	0.1 mg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	0.2 mg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	0.25 mg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	0.4 mg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	0.5 mg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	0.8 mg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	1 mg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	1.6 mg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	2 mg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	3.2 mg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	4 mg	Subcutaneous
Subject	Pembrolizumab	Monoclonal antibody	2 mg/kg	Intravenous
Background	Capecitabine	Small molecule	1000 mg/m2	Oral
Background	Carboplatin	Small molecule	—	Intravenous
Background	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Background	Docetaxel	Small molecule	65 mg/m2	Intravenous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Gemcitabine	Small molecule	500 mg/m2	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Background	Leucovorin	Small molecule	200 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	125 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	175 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	200 mg/m2	Intravenous
Background	Pazopanib	Small molecule	800 mg	Oral
Background	fluorouracil	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	600 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications