This study is in progress, not accepting new patients

A Phase 1 Study of AM0010 in Patients With Advanced Solid Tumors

a study on Skin Cancer/Melanoma Prostate Cancer Ovarian Cancer Kidney Cancer Colorectal Cancer Pancreatic Cancer Lung Cancer Solid Tumor Breast Cancer

Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Pamela Munster

Description

Summary

This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of AM0010 in patients 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 Carcinoma, Renal Cell Lung Neoplasms Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Pancreatic Neoplasms Paclitaxel Docetaxel Gemcitabine Oxaliplatin Pembrolizumab Nivolumab Albumin-Bound Paclitaxel Cisplatin Carboplatin Capecitabine Fluorouracil AM0010 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 patient 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
  • Patients must have failed prior standard curative chemotherapy for their disease,refuse existing therapies OR the proposed chemotherapy regimen to which AM0010 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
ARMO BioSciences
ID
NCT02009449
Phase
Phase 1
Lead Scientist
Pamela Munster
Study Type
Interventional
Last Updated
March 14, 2018