NCT02009449

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2013-11-15
• Primary completion: 2019-02-19
• Completion: 2023-07-22
• First posted: 2013-12-12
• Last updated: 2024-11-15

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study