A Phase 1 Study Of Pegilodecakin (LY3500518) In Participants With Advanced Solid Tumors

Study Overview

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

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.

N/A

Melanoma
Prostate Cancer
Ovarian Cancer
Renal Cell Carcinoma
Colorectal Carcinoma
Pancreatic Carcinoma
Non-small Cell Lung Carcinoma
Solid Tumors
Breast Cancer

DRUG: Pegilodecakin
DRUG: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
DRUG: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
DRUG: gemcitabine/nab-paclitaxel
DRUG: Capecitabine
DRUG: Pazopanib
DRUG: Pembrolizumab
DRUG: Paclitaxel
DRUG: nivolumab
DRUG: Gemcitabine/carboplatin

17159
J1L-AM-JZGA (OTHER Identifier) (OTHER: Eli Lilly and Company)
AM0010-001 (OTHER Identifier) (OTHER: ARMO BioSciences)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-12-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-11-13
First Submitted that Met QC Criteria 2013-12-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-11-15
First Posted (ACTUAL) 2013-12-12	Results First Posted N/A	Last Verified 2024-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Part A: Dose Escalation Cohort 1 Pegilodecakin (1 ug/kg) - Daily subcutaneous (SC) injections of pegilodecakin for up to 22 months	DRUG: Pegilodecakin Daily subcutaneous injections of pegilodecakin up to 12 months
EXPERIMENTAL: Part A: Dose Escalation Cohort 2 Pegilodecakin (2.5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months	DRUG: Pegilodecakin Daily subcutaneous injections of pegilodecakin up to 12 months
EXPERIMENTAL: Part A: Dose Escalation Cohort 3 Pegilodecakin (5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months	DRUG: Pegilodecakin Daily subcutaneous injections of pegilodecakin up to 12 months
EXPERIMENTAL: Part A: Dose Escalation Cohort 4 Pegilodecakin (10 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months	DRUG: Pegilodecakin Daily subcutaneous injections of pegilodecakin up to 12 months
EXPERIMENTAL: Part A: Dose Escalation Cohort 5 Pegilodecakin (20 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months	DRUG: Pegilodecakin Daily subcutaneous injections of pegilodecakin up to 12 months
EXPERIMENTAL: Part A: Dose Escalation Cohort 6 Pegilodecakin (40 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months	DRUG: Pegilodecakin Daily subcutaneous injections of pegilodecakin up to 12 months
EXPERIMENTAL: Part A: Dose Expansion Cohort 1 at least 15 RCC participants will be dosed with pegilodecakin for up to 22 months	DRUG: Pegilodecakin Daily subcutaneous injections of pegilodecakin up to 12 months
EXPERIMENTAL: Part B: Dose Escalation Cohort 1 Pegilodecakin (2.5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 * Paclitaxel 200/175 mg/m2 IV, or * Docetaxel 75/65 mg/m2 IV And * Carboplatin AUC 6/5/4 (max. 6x 150mg) IV	DRUG: Paclitaxel or Docetaxel and Carboplatin or Cisplatin Day 1 of every 21 day cycle
EXPERIMENTAL: Part B: Dose Escalation Cohort 2 Pegilodecakin (5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 * Paclitaxel 200/175 mg/m2 IV, or * Docetaxel 75/65 mg/m2 IV And * Carboplatin AUC 6/5/4 (max. 6x 150mg) IV o	DRUG: Paclitaxel or Docetaxel and Carboplatin or Cisplatin Day 1 of every 21 day cycle
EXPERIMENTAL: Part B: Dose Escalation Cohort 3 Pegilodecakin (10 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 * Paclitaxel 200/175 mg/m2 IV, or * Docetaxel 75/65 mg/m2 IV And * Carboplatin AUC 6/5/4 (max. 6x 150mg) IV	DRUG: Paclitaxel or Docetaxel and Carboplatin or Cisplatin Day 1 of every 21 day cycle
EXPERIMENTAL: Part B: Dose Expansion Cohort Daily SC injection with pegilodecakin with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 * Paclitaxel 200/175 mg/m2 IV, or * Docetaxel 75/65 mg/m2 IV And * Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or * Cisplatin 75	DRUG: Paclitaxel or Docetaxel and Carboplatin or Cisplatin Day 1 of every 21 day cycle
EXPERIMENTAL: Part C: Dose Escalation Cohort 1 Pegilodecakin (2.5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 * Oxaliplatin 85 mg/m2 IV over 2 hours * Leucovorin 200 mg/m2 IV over 2 hours followed by * 5-FU 400 mg/m2 IV bolus and * 5-FU 600 mg	DRUG: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) Intravenous administration on Day 1 and 2 of every 14 day cycle
EXPERIMENTAL: Part C: Dose Escalation Cohort 2 Pegilodecakin (5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 * Oxaliplatin 85 mg/m2 IV over 2 hours * Leucovorin 200 mg/m2 IV over 2 hours followed by * 5-FU 400 mg/m2 IV bolus and * 5-FU 600 mg/m	DRUG: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) Intravenous administration on Day 1 and 2 of every 14 day cycle
EXPERIMENTAL: Part C: Dose Escalation Cohort 3 Pegilodecakin (10 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 * Oxaliplatin 85 mg/m2 IV over 2 hours * Leucovorin 200 mg/m2 IV over 2 hours followed by * 5-FU 400 mg/m2 IV bolus and * 5-FU 600 mg/	DRUG: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) Intravenous administration on Day 1 and 2 of every 14 day cycle
EXPERIMENTAL: Part C: Dose Expansion Cohort 1 Daily SC injection with pegilodecakin with FOLFOX4 Every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 * Oxaliplatin 85 mg/m2 IV over 2 hours * Leucovorin 200 mg/m2 IV over 2 hours followed by * 5-FU 400 mg/m2 IV bolus and * 5-FU 600 mg/m2/day IV over 22	DRUG: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) Intravenous administration on Day 1 and 2 of every 14 day cycle
EXPERIMENTAL: Part D: Dose Escalation Cohort 1 Pegilodecakin (5 ug/kg) daily subcutaneous injections with Gemcitabine and nab-paclitaxel on Days 1, 8, 15 of each cycle (28 days = 1 cycle). Nab-paclitaxel 125 mg/m2 IV over 30 minutes followed by • Gemcitabine 1000 mg/m2 IV.	DRUG: gemcitabine/nab-paclitaxel Intravenous administration of the gemcitabine/nab-paclitaxel regimen on Day 1, 8 and 15 of each 28 day treatment cycle.
EXPERIMENTAL: Part E: Dose Escalation Cohort 1 Pegilodecakin (10 ug/kg) daily subcutaneous injections with capecitabine BID daily for 14 days of each cycle (21 days= 1 cycle). • Capecitabine 1000 mg/m2 po BID	DRUG: Capecitabine Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
EXPERIMENTAL: Part F: Dose Escalation Cohort 1 Pegilodecakin (10 ug/kg) daily subcutaneous injections with paclitaxel on Days 1, 8, 15 of each cycle (28 days= 1 cycle) • Paclitaxel 80 mg/ m2 IV	DRUG: Paclitaxel Paclitaxel will be administered intravenously on Days 1, 8, 15 of each cycle (28 days= 1 cycle) • Paclitaxel 80 mg/ m2 IV
EXPERIMENTAL: Part G: Dose Escalation Cohort 1 Pegilodecakin (10 ug/kg) daily subcutaneous injections with pazopanib orally given daily for 14 days of each cycle (21 days= 1 cycle) • Pazopanib 800 mg po QD	DRUG: Pazopanib Pazopanib will be administered orally daily continuously
EXPERIMENTAL: Part H: Dose Escalation Cohort 1 Pegilodecakin (10 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min	DRUG: Pembrolizumab Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
EXPERIMENTAL: Part I: Dose Escalation Cohort 1 Pegilodecakin (20 ug/kg) daily subcutaneous injections with nivolumab on Day 1 of each cycle (14 days= 1 cycle). • Nivolumab 3 mg/kg IV over 60 min	DRUG: nivolumab Nivolumab on Day 1 of each cycle (14 days = 1 cycle)
EXPERIMENTAL: Part H: Dose Escalation Cohort 2 Pegilodecakin (20 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min	DRUG: Pembrolizumab Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
EXPERIMENTAL: Part H: Dose Escalation Cohort 3 Pegilodecakin (40 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min	DRUG: Pembrolizumab Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
EXPERIMENTAL: Part J: Dose Escalation Cohort 1 Pegilodecakin (10 ug/kg) daily subcutaneous injections with gemcitabine and carbolplatin on Days 1,8 of each cycle (21 days=1 cycle) until disease progression gemcitabine 1000mg/m2 IV over 30 minutes followed by carboplatin AUC2 over 60 minutes	DRUG: Gemcitabine/carboplatin gemcitabine and carboplatin on Days 1, 8 of each cycle (21 days = 1 cycle)

Primary Outcome Measures	Measure Description	Time Frame
Safety and tolerability as measured by incidence of adverse events		up to 12 months
Pharmacokinetic (PK) parameters	PK parameters including the serum trough concentration (Minimal Drug Concentration (Cmin)), the maximal drug concentration (Cmax), area under the curve of serum concentration over time (Area Under the Curve/ AUC), and half-life (t½).	up to 12 months

Secondary Outcome Measures	Measure Description	Time Frame
Change in tumor burden measured by volumetric Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) according to immune-related response criteria (irRC)		up to 12 months
Progression in bone by bone scintigraphy according to Prostate Cancer Working Group 2 (PCWG2) for participants with metastatic castration resistant prostate cancer (CRPC)		approximatley 4 months
Anti-Pegilodecakin antibody formation		up to 12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Tumors with all histological diagnosis or tissue origin may be enrolled
Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease.

Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC)
At least 18 years of age
Performance Status of 0 or 1
Adequate organ function

Hematologic malignancies
Pregnant or lactating
Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders
Myocardial infarction within the last 6 months
Unstable angina, or unstable cardiac arrhythmia requiring medication
Surgery within the last 28 days
Systemic fungal, bacterial, viral, or other infection
History of bleeding diathesis within the last 6 months
Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

ARMO BioSciences

Investigators

STUDY_DIRECTOR: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

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