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COMPLETED
NCT02009449
PHASE1

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

353

Start Date

2013-11-15

Completion Date

2023-07-22

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

DRUG

Pegilodecakin

Daily subcutaneous injections of pegilodecakin up to 12 months

DRUG

Paclitaxel or Docetaxel and Carboplatin or Cisplatin

Platinum/ Taxane administered IV on Day 1 of every 21 day cycle

DRUG

FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)

FOLFOX administered IV on Day 1 and 2 of every 14 day cycle

DRUG

gemcitabine/nab-paclitaxel

Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle.

DRUG

Capecitabine

Capecitabine administered orally twice daily for 14 days out of every 21 days.

DRUG

Pazopanib

Pazopanib administered orally daily continuously

DRUG

Pembrolizumab

Pembrolizumab administered IV on Day 1 of every 21 day cycle.

DRUG

Paclitaxel

Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle)

DRUG

nivolumab

Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)

DRUG

Gemcitabine/carboplatin

Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)

Locations (10)

UCLA Medical Hematology & Oncology

Los Angeles, California, United States

UCSF

San Francisco, California, United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Florida Cancer Specialists & Research Institute

Sarasota, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, 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

Sarah Cannon Research Institute

Nashville, Tennessee, United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States