Clinical trial · Interventional
A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors
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
NCT02009449CI-TRIAL-00117462IVYcompletedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non-small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Carcinoma | Pancreatic Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) | Drug | FOLFOX Regimen | ALIAS |
| Gemcitabine/carboplatin | Drug | — | UNRESOLVED |
| gemcitabine/nab-paclitaxel | Drug | — | UNRESOLVED |
| nivolumab | Drug | Nivolumab | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Paclitaxel or Docetaxel and Carboplatin or Cisplatin | Drug | — | UNRESOLVED |
| Pazopanib | Drug | Pazopanib | ALIAS |
Design
Arms and outcomes
Arms (23)
- type
- EXPERIMENTAL
- label
- Part A: Pegilodecakin 0.08/0.1 mg
- description
- 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.
- interventionNames
- Drug: Pegilodecakin
- type
- EXPERIMENTAL
- label
- Part A: Pegilodecakin 0.2/0.25 mg
- description
- 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.
- interventionNames
- Drug: Pegilodecakin
- type
- EXPERIMENTAL
- label
- Part A: Pegilodecakin 0.4/0.5 mg
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Part A Escalation Cohorts: o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts: * Tumors with all histological diagnosis or tissue origin may be enrolled * Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease. * Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC) * At least 18 years of age * Performance Status of 0 or 1 * Adequate organ function Exclusion Criteria: * Hematologic malignancies * Pregnant or lactating * Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders * Myocardial infarction within the last 6 months * Unstable angina, or unstable cardiac arrhythmia requiring medication * Surgery within the last 28 days * Systemic fungal, bacterial, viral, or other infection * History of bleeding diathesis within the last 6 months * Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
References
Publications (2)
- DERIVEDNaing A, Wong DJ, Infante JR, Korn WM, Aljumaily R, Papadopoulos KP, Autio KA, Pant S, Bauer TM, Drakaki A, Daver NG, Hung A, Ratti N, McCauley S, Van Vlasselaer P, Verma R, Ferry D, Oft M, Diab A, Garon EB, Tannir NM. Pegilodecakin combined with pembrolizumab or nivolumab for patients with advanced solid tumours (IVY): a multicentre, multicohort, open-label, phase 1b trial. Lancet Oncol. 2019 Nov;20(11):1544-1555. doi: 10.1016/S1470-2045(19)30514-5. Epub 2019 Sep 25. PMID 31563517
- DERIVEDNaing A, Papadopoulos KP, Autio KA, Ott PA, Patel MR, Wong DJ, Falchook GS, Pant S, Whiteside M, Rasco DR, Mumm JB, Chan IH, Bendell JC, Bauer TM, Colen RR, Hong DS, Van Vlasselaer P, Tannir NM, Oft M, Infante JR. Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human Interleukin-10 (AM0010) in Patients With Advanced Solid Tumors. J Clin Oncol. 2016 Oct 10;34(29):3562-3569. doi: 10.1200/JCO.2016.68.1106. PMID 27528724