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

January 23, 2024 updated by: Eli Lilly and Company

A Phase 1, Open-Label Dose Escalation First-in-Human Study to Evaluate the Tolerability, Safety, Maximum Tolerated Dose, Preliminary Clinical Activity and Pharmacokinetics of AM0010 in Patients 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • UCLA Medical Hematology & Oncology
      • San Francisco, California, United States
        • UCSF
    • Colorado
      • Denver, Colorado, United States, 80218
        • Sarah Cannon Research Institute at HealthONE
    • Florida
      • Sarasota, Florida, United States, 34232
        • Florida Cancer Specialists & Research Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas M.D. Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Part A Escalation Cohorts:

o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies

Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts:

  • 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

Exclusion Criteria:

  • 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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
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
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
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
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
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
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
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
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
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
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
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
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
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 or
  • Cisplatin 75mg/m2 IV
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Day 1 of every 21 day cycle
Other Names:
  • Taxol or taxotere and paraplatin or platinol
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 or
  • Cisplatin 75mg/m2 IV
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Day 1 of every 21 day cycle
Other Names:
  • Taxol or taxotere and paraplatin or platinol
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 or
  • Cisplatin 75mg/m2 IV
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Day 1 of every 21 day cycle
Other Names:
  • Taxol or taxotere and paraplatin or platinol
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 75mg/m2 IV
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Day 1 of every 21 day cycle
Other Names:
  • Taxol or taxotere and paraplatin or platinol
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/m2/day IV over 22 hours
  • Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Intravenous administration on Day 1 and 2 of every 14 day cycle
Other Names:
  • Eloxatin®/Leucovorin/5-FU
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/m2/day IV over 22 hours
  • Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Intravenous administration on Day 1 and 2 of every 14 day cycle
Other Names:
  • Eloxatin®/Leucovorin/5-FU
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/m2/day IV over 22 hours
  • Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Intravenous administration on Day 1 and 2 of every 14 day cycle
Other Names:
  • Eloxatin®/Leucovorin/5-FU
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 hours
  • Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Intravenous administration on Day 1 and 2 of every 14 day cycle
Other Names:
  • Eloxatin®/Leucovorin/5-FU
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: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: gemcitabine/nab-paclitaxel
Intravenous administration of the gemcitabine/nab-paclitaxel regimen on Day 1, 8 and 15 of each 28 day treatment cycle.
Other Names:
  • Gemzar/Abraxane ABI-007
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: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Capecitabine
Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
Other Names:
  • Xeloda
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: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
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: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Pazopanib
Pazopanib will be administered orally daily continuously
Other Names:
  • GW786034
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: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Pembrolizumab
Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
Other Names:
  • Keytruda, MK-3475
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)
Other Names:
  • Keytruda
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.
Other Names:
  • Keytruda, MK-3475
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.
Other Names:
  • Keytruda, MK-3475
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)
Other Names:
  • gemzar/paraplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability as measured by incidence of adverse events
Time Frame: up to 12 months
up to 12 months
Pharmacokinetic (PK) parameters
Time Frame: up to 12 months
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

Outcome Measure
Time Frame
Change in tumor burden measured by volumetric Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) according to immune-related response criteria (irRC)
Time Frame: up to 12 months
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)
Time Frame: approximatley 4 months
approximatley 4 months
Anti-Pegilodecakin antibody formation
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

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

Sponsor

Eli Lilly and Company

Collaborators

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 and helpful links

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

General Publications

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 Major Dates

Study Start (Actual)

November 15, 2013

Primary Completion (Actual)

February 19, 2019

Study Completion (Estimated)

August 25, 2024

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

December 9, 2013

First Posted (Estimated)

December 12, 2013

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melanoma

Clinical Trials on Pegilodecakin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe