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

NCT02009449 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2024-11-15

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • 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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-15
Primary Completion
2019-02-19
Completion
2023-07-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02009449 on ClinicalTrials.gov