Melanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma, Colorectal Carcinoma, Pancreatic Carcinoma, Non-small Cell Lung Carcinoma, Solid Tumors, Breast Cancer
Conditions
Keywords
Phase 1/Phase 1b, Oncology, Cancer, Solid Tumors
Brief 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.
Interventions
DRUGPegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
DRUGPaclitaxel or Docetaxel and Carboplatin or Cisplatin
Day 1 of every 21 day cycle
Intravenous administration on Day 1 and 2 of every 14 day cycle
Intravenous administration of the gemcitabine/nab-paclitaxel regimen on Day 1, 8 and 15 of each 28 day treatment cycle.
DRUGCapecitabine
Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
DRUGPazopanib
Pazopanib will be administered orally daily continuously
DRUGPembrolizumab
Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
DRUGPaclitaxel
Paclitaxel will be administered intravenously on Days 1, 8, 15 of each cycle (28 days= 1 cycle) • Paclitaxel 80 mg/ m2 IV
DRUGnivolumab
Nivolumab on Day 1 of each cycle (14 days = 1 cycle)
gemcitabine and carboplatin on Days 1, 8 of each cycle (21 days = 1 cycle)
Sponsors
ARMO BioSciences
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability as measured by incidence of adverse events | up to 12 months | — |
| Pharmacokinetic (PK) parameters | up to 12 months | PK parameters including the serum trough concentration (Minimal Drug Concentration (Cmin)), the maximal drug concentration (Cmax), area under the curve of serum concentration over time (Area Under the Curve/ AUC), and half-life (t½). |
Secondary
| Measure | Time frame |
|---|---|
| Change in tumor burden measured by volumetric Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) according to immune-related response criteria (irRC) | up to 12 months |
| Progression in bone by bone scintigraphy according to Prostate Cancer Working Group 2 (PCWG2) for participants with metastatic castration resistant prostate cancer (CRPC) | approximatley 4 months |
| Anti-Pegilodecakin antibody formation | up to 12 months |
Countries
United States
Outcome results
None listed