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
  Day 1 of every 21 day cycle
• FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) — DRUG
  Intravenous administration on Day 1 and 2 of every 14 day cycle
• gemcitabine/nab-paclitaxel — DRUG
  Intravenous administration of the gemcitabine/nab-paclitaxel regimen on Day 1, 8 and 15 of each 28 day treatment cycle.
• Capecitabine — DRUG
  Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
• Pazopanib — DRUG
  Pazopanib will be administered orally daily continuously
• Pembrolizumab — DRUG
  Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
• Paclitaxel — DRUG
  Paclitaxel will be administered intravenously on Days 1, 8, 15 of each cycle (28 days= 1 cycle) • Paclitaxel 80 mg/ m2 IV
• nivolumab — DRUG
  Nivolumab on Day 1 of each cycle (14 days = 1 cycle)
• Gemcitabine/carboplatin — DRUG
  gemcitabine and carboplatin 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

Start date

Nov 15, 2013

Status verified

Nov 2024

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: Dose Escalation Cohort 1
  Pegilodecakin (1 ug/kg) - Daily subcutaneous (SC) injections of pegilodecakin for up to 22 months
• Experimental: Part A: Dose Escalation Cohort 2
  Pegilodecakin (2.5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
• Experimental: Part A: Dose Escalation Cohort 3
  Pegilodecakin (5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
• Experimental: Part A: Dose Escalation Cohort 4
  Pegilodecakin (10 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
• Experimental: Part A: Dose Escalation Cohort 5
  Pegilodecakin (20 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
• Experimental: Part A: Dose Escalation Cohort 6
  Pegilodecakin (40 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
• Experimental: Part A: Dose Expansion Cohort 1
  at least 15 RCC participants will be dosed with pegilodecakin for up to 22 months
• Experimental: Part B: Dose Escalation Cohort 1
  Pegilodecakin (2.5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 * Paclitaxel 200/175 mg/m2 IV, or * Docetaxel 75/65 mg/m2 IV And * Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or * Cisplatin 75mg/m2 IV
• Experimental: Part B: Dose Escalation Cohort 2
  Pegilodecakin (5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 * Paclitaxel 200/175 mg/m2 IV, or * Docetaxel 75/65 mg/m2 IV And * Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or * Cisplatin 75mg/m2 IV
• Experimental: Part B: Dose Escalation Cohort 3
  Pegilodecakin (10 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 * Paclitaxel 200/175 mg/m2 IV, or * Docetaxel 75/65 mg/m2 IV And * Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or * Cisplatin 75mg/m2 IV
• Experimental: Part B: Dose Expansion Cohort
  Daily SC injection with pegilodecakin with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 * Paclitaxel 200/175 mg/m2 IV, or * Docetaxel 75/65 mg/m2 IV And * Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or * Cisplatin 75mg/m2 IV
• Experimental: Part C: Dose Escalation Cohort 1
  Pegilodecakin (2.5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 * Oxaliplatin 85 mg/m2 IV over 2 hours * Leucovorin 200 mg/m2 IV over 2 hours followed by * 5-FU 400 mg/m2 IV bolus and * 5-FU 600 mg/m2/day IV over 22 hours * Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by * 5-FU 400 mg/m2 IV bolus and * 5-FU 600 mg/m2/day IV over 22 hours
• Experimental: Part C: Dose Escalation Cohort 2
  Pegilodecakin (5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 * Oxaliplatin 85 mg/m2 IV over 2 hours * Leucovorin 200 mg/m2 IV over 2 hours followed by * 5-FU 400 mg/m2 IV bolus and * 5-FU 600 mg/m2/day IV over 22 hours * Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by * 5-FU 400 mg/m2 IV bolus and * 5-FU 600 mg/m2/day IV over 22 hours
• Experimental: Part C: Dose Escalation Cohort 3
  Pegilodecakin (10 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 * Oxaliplatin 85 mg/m2 IV over 2 hours * Leucovorin 200 mg/m2 IV over 2 hours followed by * 5-FU 400 mg/m2 IV bolus and * 5-FU 600 mg/m2/day IV over 22 hours * Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by * 5-FU 400 mg/m2 IV bolus and * 5-FU 600 mg/m2/day IV over 22 hours
• Experimental: Part C: Dose Expansion Cohort 1
  Daily SC injection with pegilodecakin with FOLFOX4 Every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 * Oxaliplatin 85 mg/m2 IV over 2 hours * Leucovorin 200 mg/m2 IV over 2 hours followed by * 5-FU 400 mg/m2 IV bolus and * 5-FU 600 mg/m2/day IV over 22 hours * Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by * 5-FU 400 mg/m2 IV bolus and * 5-FU 600 mg/m2/day IV over 22 hours
• Experimental: Part D: Dose Escalation Cohort 1
  Pegilodecakin (5 ug/kg) daily subcutaneous injections with Gemcitabine and nab-paclitaxel on Days 1, 8, 15 of each cycle (28 days = 1 cycle). Nab-paclitaxel 125 mg/m2 IV over 30 minutes followed by • Gemcitabine 1000 mg/m2 IV.
• Experimental: Part E: Dose Escalation Cohort 1
  Pegilodecakin (10 ug/kg) daily subcutaneous injections with capecitabine BID daily for 14 days of each cycle (21 days= 1 cycle). • Capecitabine 1000 mg/m2 po BID
• Experimental: Part F: Dose Escalation Cohort 1
  Pegilodecakin (10 ug/kg) daily subcutaneous injections with paclitaxel on Days 1, 8, 15 of each cycle (28 days= 1 cycle) • Paclitaxel 80 mg/ m2 IV
• Experimental: Part G: Dose Escalation Cohort 1
  Pegilodecakin (10 ug/kg) daily subcutaneous injections with pazopanib orally given daily for 14 days of each cycle (21 days= 1 cycle) • Pazopanib 800 mg po QD
• Experimental: Part H: Dose Escalation Cohort 1
  Pegilodecakin (10 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min
• Experimental: Part I: Dose Escalation Cohort 1
  Pegilodecakin (20 ug/kg) daily subcutaneous injections with nivolumab on Day 1 of each cycle (14 days= 1 cycle). • Nivolumab 3 mg/kg IV over 60 min
• Experimental: Part H: Dose Escalation Cohort 2
  Pegilodecakin (20 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min
• Experimental: Part H: Dose Escalation Cohort 3
  Pegilodecakin (40 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min
• Experimental: Part J: Dose Escalation Cohort 1
  Pegilodecakin (10 ug/kg) daily subcutaneous injections with gemcitabine and carbolplatin on Days 1,8 of each cycle (21 days=1 cycle) until disease progression gemcitabine 1000mg/m2 IV over 30 minutes followed by carboplatin AUC2 over 60 minutes

Primary Outcome Measure

Safety and tolerability as measured by incidence of adverse events [ Time Frame: up to 12 months ]

Locations (10)

Find similar trials in Los Angeles, CA

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