Summary

for people ages 18 years and up (full criteria)
at UCLAUCSF
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

MelanomaProstate CancerOvarian CancerRenal Cell CarcinomaColorectal CarcinomaPancreatic CarcinomaNon-small Cell Lung CarcinomaSolid TumorsBreast CancerPhase 1/Phase 1bOncologyCancerCarcinomaCarcinoma, Renal CellLung NeoplasmsCarcinoma, Non-Small-Cell LungColorectal NeoplasmsPancreatic NeoplasmsPaclitaxelDocetaxelAlbumin-Bound PaclitaxelCisplatinGemcitabineCarboplatinCapecitabineOxaliplatinPembrolizumabNivolumabFluorouracilPegilodecakinPaclitaxel or Docetaxel and Carboplatin or CisplatinFOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)gemcitabine/nab-paclitaxelPazopanibGemcitabine/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

  • UCLA Medical Hematology & Oncology
    Los AngelesCalifornia90024United States
  • UCSF
    San FranciscoCaliforniaUnited States

Details

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