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Drug

Pegilodecakin

Late-stage clinical development
ClassIL-10 receptor agonist

Also known as INTERLEUKIN 10 (SYNTHETIC HUMAN), DIMER, N-TERMINAL 5-KILODALTON PEGYLATED.

RxNorm2169746ChEMBLCHEMBL3989992UNII5Z9850I25F
2
Protein targets
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-07-09Results posted · ClinicalTrials.gov

An Open Label, Randomized, Single Dose, 3-Way Crossover Study to Evaluate the Pharmacokinetics of Different Dose Levels and Dose Formulations of AM0010 in Healthy Adult Subjects

Clinical trial2026-07-07Results posted · ClinicalTrials.gov

Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Metastatic Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen

Clinical trial2020-10-19Results posted · ClinicalTrials.gov

A Randomized Phase 2 Trial of AM0010 in Combination With Pembrolizumab vs. Pembrolizumab Alone as First-Line (1L) Therapy in Patients With Stage IV / Metastatic Wild Type (WT) Non-Small Cell Lung Cancer and Tumors With High Expression of PD-L1 (> 50%)

Clinical trial2020-03-05Terminated · ClinicalTrials.gov

A Randomized Phase 2 Trial of AM0010 in Combination With Nivolumab vs. Nivolumab Alone as Second-Line Therapy in Subjects With Stage IV / Metastatic Wild Type Non-Small Cell Lung Cancer and Low Tumor Expression of PD-L1

Clinical trial2020-03-03Terminated · ClinicalTrials.gov

An Open Label, Randomized, Single Dose, 2-Way Crossover Study to Evaluate the Pharmacokinetics of Pre-filled Syringe Versus Vial Formulations of AM0010 in Healthy Adult Subjects

Clinical trial2018-03-14Completed · ClinicalTrials.gov

A Phase 1 Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of AM0010 in Healthy Adult Subjects

Clinical trial2017-10-30Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Pegilodecakin
Aliases & brands
INTERLEUKIN 10 (SYNTHETIC HUMAN), DIMER, N-TERMINAL 5-KILODALTON PEGYLATED
RxNorm CUI
2169746
ChEMBL ID
CHEMBL3989992
UNII
5Z9850I25F
Primary mechanism
IL-10 receptor agonist

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Interleukin-10 receptor subunit beta
IL10RB · Q08334
AGONISTIL-10 receptor agonist
Interleukin-10 receptor subunit alpha
IL10RA · Q13651
AGONISTIL-10 receptor agonist

Clinical trials

7 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
7
registered trials across all phases
LATEST COMPLETION 2023
1
Late-stage (III+)
5
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 7
Phase 14Phase 22Phase 31

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Metastatic Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen

CompletedPH IIIEli Lilly and Companyn=5672020

Recent completions

Trials that read out recently, adding to the completed evidence base.

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

CompletedPH IEli Lilly and Companyn=3532023

Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Metastatic Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen

CompletedPH IIIEli Lilly and Companyn=5672020

An Open Label, Randomized, Single Dose, 2-Way Crossover Study to Evaluate the Pharmacokinetics of Pre-filled Syringe Versus Vial Formulations of AM0010 in Healthy Adult Subjects

CompletedPH IEli Lilly and Companyn=122018

An Open Label, Randomized, Single Dose, 3-Way Crossover Study to Evaluate the Pharmacokinetics of Different Dose Levels and Dose Formulations of AM0010 in Healthy Adult Subjects

CompletedPH IEli Lilly and Companyn=122018

A Phase 1 Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of AM0010 in Healthy Adult Subjects

CompletedPH IEli Lilly and Companyn=242017
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials