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

This study is currently recruiting participants.
Verified January 2014 by ARMO BioSciences
Sponsor:
Information provided by (Responsible Party):
ARMO BioSciences
ClinicalTrials.gov Identifier:
NCT02009449
First received: December 2, 2013
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Melanoma
Prostate Cancer
Ovarian Cancer
Renal Cell Carcinoma
Colorectal Carcinoma
Pancreatic Carcinoma
Non-small Cell Lung Carcinoma
Drug: AM0010
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label Dose Escalation First-in-Human Study to Evaluate the Tolerability, Safety, Maximum Tolerated Dose, and Pharmacokinetics of AM0010 in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by ARMO BioSciences:

Primary Outcome Measures:
  • Safety and tolerability as measured by incidence of adverse events [ Time Frame: approximately 4 months ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic (PK) parameters [ Time Frame: Approximately 4 months ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Change in tumor burden measured by volumetric Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) according to immune-related response criteria (irRC) [ Time Frame: approxinatetly 4 months ] [ Designated as safety issue: No ]
  • Progression in bone by bone scintigraphy according to Prostate Cancer Working Group 2 (PCWG2) for patients with metastatic castration resistant prostate cancer (CRPC) [ Time Frame: approximatley 4 months ] [ Designated as safety issue: No ]
  • Anti-AM0010 antibody formation [ Time Frame: approximately 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Escalation Cohort 1
AM0010 (1 ug/kg) - Daily subcutaneous (SC) injections of AM0010 for up to 4 cycles of 28 days
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 4 cycles of 28 days
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Dose Escalation Cohort 2
AM0010 (2.5 ug/kg) - Daily subcutaneous injections of AM0010 for up to 4 cycles of 28 days
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 4 cycles of 28 days
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Dose Escalation Cohort 3
AM0010 (5 ug/kg) - Daily subcutaneous injections of AM0010 for up to 4 cycles of 28 days
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 4 cycles of 28 days
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Dose Escalation Cohort 4
AM0010 (10 ug/kg) - Daily subcutaneous injections of AM0010 for up to 4 cycles of 28 days
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 4 cycles of 28 days
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Dose Escalation Cohort 5
AM0010 (20 ug/kg) - Daily subcutaneous injections of AM0010 for up to 4 cycles of 28 days
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 4 cycles of 28 days
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Dose Expansion Cohort
at least 15 patients will be dosed with AM0010
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 4 cycles of 28 days
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced solid tumor, limited to melanoma, hormone refractory prostate cancer, ovarian cancer, 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02009449

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Caryn Kata    617-582-7603      
Principal Investigator: Patrick Ott, MD, Phd         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Karen Autio, MD    646-888-3359      
Principal Investigator: Karen Autio, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Julie Pfrommer Fey    615-524-4110    julie.pfrommer@scresearch.net   
Principal Investigator: Jeffrey Infante, MD         
United States, Texas
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez, RN, MSN    210-593-5265    isabel.jimenez@start.stoh.com   
Principal Investigator: Kyrakos Papadopoulos, MD         
Sponsors and Collaborators
ARMO BioSciences
Investigators
Study Director: Martin Oft, MD ARMO
  More Information

No publications provided

Responsible Party: ARMO BioSciences
ClinicalTrials.gov Identifier: NCT02009449     History of Changes
Other Study ID Numbers: AM0010-001
Study First Received: December 2, 2013
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by ARMO BioSciences:
Phase 1
Oncology
Cancer
Solid Tumors

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Colorectal Neoplasms
Lung Neoplasms
Melanoma
Ovarian Neoplasms
Pancreatic Neoplasms
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 17, 2014