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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed

Dec 12, 2013

Start date

Nov 15, 2013

Status verified

Jun 2026

Primary completion

Feb 19, 2019

Completion

Jul 22, 2023

Study Design

Enrollment

353 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Part A: Pegilodecakin 0.08/0.1 mg
  Participants received 0.08 or 0.1 mg of Pegilodecakin once daily (QD) administered subcutaneously (SC). Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part A: Pegilodecakin 0.2/0.25 mg
  Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part A: Pegilodecakin 0.4/0.5 mg
  Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part A: Pegilodecakin 0.8/1 mg
  Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part A: Pegilodecakin 1.6/2 mg
  Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part A: Pegilodecakin 3.2/4 mg
  Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane
  Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane
  Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane
  Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX
  Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-Fluorouracil (FU) 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX
  Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part C: Pegilodecakin 0.8/1 mg + FOLFOX
  Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part D: Pegilodecakin 0.4/ 0.5 mg + Gemcitabine/Nab-Paclitaxel
  Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with Gemcitabine 1000 mg/m2 IV over 30 minutes plus nab-paclitaxel 125 mg/m2 IV over 30 to 40 minutes on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part E: Pegilodecakin 0.8/1 mg + Capecitabine
  Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Capecitabine 1000 mg/m² orally twice daily (BID) on Days 1 through 14 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part F: Pegilodecakin 0.8/ 1 mg + Paclitaxel
  Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Paclitaxel 80 mg/m2 IV over 3 hours on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part G: Pegilodecakin 0.8/1 mg + Pazopanib
  Participants received a 0.8 or 1 mg of Pegilodecakin QD administered SC with Pazopanib 800 mg orally QD. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab
  Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab
  Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab
  Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin
  Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an Area Under the Curve of 2 mg/mL x min (AUC2) IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part I: Pegilodecakin 1.6/2 mg + Nivolumab
  Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part I: Pegilodecakin 0.8/1 mg + Nivolumab
  Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
• Experimental: Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin
  Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an AUC2 IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Primary Outcome Measure

Number of Participants With TEAEs and SAEs Observed During the Study of Pegilodecakin [ Time Frame: From first dose of study drug through 30 days after the last dose of study drug (Up to 63 Months) ]

Locations (10)

Related coverage on Hipa.ai

• Pegilodecakin Phase 1 Trial Safety Data Posted for Advanced Solid Tumors
  Nivolumab · Jul 9, 2026 · ClinicalTrials.gov

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