This study is in progress, not accepting new patients

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

a study on Melanoma Skin Cancer/Melanoma Prostate Cancer Ovarian Cancer Kidney Cancer Renal Cell Carcinoma Colorectal Cancer Pancreatic Cancer Lung Cancer Non-Small Cell Lung Cancer Solid Tumor Breast Cancer Carcinoma Colorectal Tumor Pancreatic Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Melanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma, Colorectal Carcinoma, Pancreatic Carcinoma, Non-small Cell Lung Carcinoma, Solid Tumors, Breast Cancer, Phase 1/Phase 1b, Oncology, Cancer, Carcinoma, Colorectal Neoplasms, Non-Small-Cell Lung Carcinoma, Pancreatic Neoplasms, Leucovorin, Gemcitabine, Paclitaxel, Docetaxel, Albumin-Bound Paclitaxel, Carboplatin, Pembrolizumab, Fluorouracil, Capecitabine, Oxaliplatin, Nivolumab, Levoleucovorin, Pegilodecakin, Paclitaxel or Docetaxel and Carboplatin or Cisplatin, FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil), gemcitabine/nab-paclitaxel, Pazopanib, Gemcitabine/carboplatin

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • 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

Locations

  • UCSF
    San Francisco California United States
  • UCLA Medical Hematology & Oncology
    Los Angeles California 90024 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT02009449
Phase
Phase 1 research study
Study Type
Interventional
Participants
About 350 people participating
Last Updated