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

Breast Cancer Clinical Trial

— IVY  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02009449
• Other study ID #: 17159
• Secondary ID: J1L-AM-JZGAAM001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 15, 2013
• Est. completion date: August 25, 2024

Study information

• Verified date: January 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: August 25, 2024
• Est. primary completion date: February 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
• Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Day 1 of every 21 day cycle
• FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Intravenous administration on Day 1 and 2 of every 14 day cycle
• gemcitabine/nab-paclitaxel
Intravenous administration of the gemcitabine/nab-paclitaxel regimen on Day 1, 8 and 15 of each 28 day treatment cycle.
• Capecitabine
Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
• Pazopanib
Pazopanib will be administered orally daily continuously
• Pembrolizumab
Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
• Paclitaxel
Paclitaxel will be administered intravenously on Days 1, 8, 15 of each cycle (28 days= 1 cycle) • Paclitaxel 80 mg/ m2 IV
• nivolumab
Nivolumab on Day 1 of each cycle (14 days = 1 cycle)
• Gemcitabine/carboplatin
gemcitabine and carboplatin on Days 1, 8 of each cycle (21 days = 1 cycle)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	ARMO BioSciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as measured by incidence of adverse events		up to 12 months
Primary	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	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
Secondary	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
Secondary	Anti-Pegilodecakin antibody formation		up to 12 months