Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by ARMO BioSciences
Sponsor:
Information provided by (Responsible Party):
ARMO BioSciences
ClinicalTrials.gov Identifier:
NCT02009449
First received: December 2, 2013
Last updated: July 16, 2014
Last verified: July 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 as a monotherapy or in combination with chemotherapy.


Condition Intervention Phase
Melanoma
Prostate Cancer
Ovarian Cancer
Renal Cell Carcinoma
Colorectal Carcinoma
Pancreatic Carcinoma
Non-small Cell Lung Carcinoma
Solid Tumors
Drug: AM0010
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Drug: FOLFOX4
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: up to 12 months ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic (PK) parameters [ Time Frame: up to 12 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: up to 12 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: up to 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 135
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: Part A: Dose Escalation Cohort 1
AM0010 (1 ug/kg) - Daily subcutaneous (SC) injections of AM0010 for up to 12 months
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Dose Escalation Cohort 2
AM0010 (2.5 ug/kg) - Daily subcutaneous injections of AM0010 for up to 12 months
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Dose Escalation Cohort 3
AM0010 (5 ug/kg) - Daily subcutaneous injections of AM0010 for up to 12 months
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Dose Escalation Cohort 4
AM0010 (10 ug/kg) - Daily subcutaneous injections of AM0010 for up to 12 months
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Dose Escalation Cohort 5
AM0010 (20 ug/kg) - Daily subcutaneous injections of AM0010 for up to 12 months
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Dose Escalation Cohort 6
AM0010 (40 ug/kg) - Daily subcutaneous injections of AM0010 for up to 12 months
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Dose Expansion Cohort
at least 15 patients will be dosed with AM0010 for up to 12 months
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part B: Dose Escalation Cohort 1

AM0010 (2.5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles.

Day 1

  • Paclitaxel 200/175 mg/m2 IV, or
  • Docetaxel 75/65 mg/m2 IV And
  • Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or
  • Cisplatin 75mg/m2 IV
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Experimental: Part B: Dose Escalation Cohort 2

AM0010 (5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles.

Day 1

  • Paclitaxel 200/175 mg/m2 IV, or
  • Docetaxel 75/65 mg/m2 IV And
  • Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or
  • Cisplatin 75mg/m2 IV
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Experimental: Part B: Dose Escalation Cohort 3

AM0010 (10 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles.

Day 1

  • Paclitaxel 200/175 mg/m2 IV, or
  • Docetaxel 75/65 mg/m2 IV And
  • Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or
  • Cisplatin 75mg/m2 IV
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Experimental: Part B: Dose Escalation Cohort 4

AM0010 (20 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles.

Day 1

  • Paclitaxel 200/175 mg/m2 IV, or
  • Docetaxel 75/65 mg/m2 IV And
  • Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or
  • Cisplatin 75mg/m2 IV
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Experimental: Part B: Dose Expansion Cohort

Daily SC injection with AM0010 with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles.

Day 1

  • Paclitaxel 200/175 mg/m2 IV, or
  • Docetaxel 75/65 mg/m2 IV And
  • Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or
  • Cisplatin 75mg/m2 IV
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Experimental: Part C: Dose Escalation Cohort 1

AM0010 (2.5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ;

Day 1

  • Oxaliplatin 85 mg/m2 IV over 2 hours
  • Leucovorin 200 mg/m2 IV over 2 hours followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
  • Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: FOLFOX4
Experimental: Part C: Dose Escalation Cohort 2

AM0010 (5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ;

Day 1

  • Oxaliplatin 85 mg/m2 IV over 2 hours
  • Leucovorin 200 mg/m2 IV over 2 hours followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
  • Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: FOLFOX4
Experimental: Part C: Dose Escalation Cohort 3

AM0010 (10 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ;

Day 1

  • Oxaliplatin 85 mg/m2 IV over 2 hours
  • Leucovorin 200 mg/m2 IV over 2 hours followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
  • Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: FOLFOX4
Experimental: Part C: Dose Escalation Cohort 4

AM0010 (20 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ;

Day 1

  • Oxaliplatin 85 mg/m2 IV over 2 hours
  • Leucovorin 200 mg/m2 IV over 2 hours followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
  • Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: FOLFOX4
Experimental: Part C: Dose Expansion Cohort 1

Daily SC injection with AM0010 with FOLFOX4 Every 14 days FOLFOX4; (14 days = 1 cycle) ;

Day 1

  • Oxaliplatin 85 mg/m2 IV over 2 hours
  • Leucovorin 200 mg/m2 IV over 2 hours followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
  • Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: FOLFOX4

  Eligibility

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

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 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Ainslie Rogers    615-524-4155    ainslie.rogers@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: July 16, 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
Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Prostatic Neoplasms
Adenocarcinoma
Adnexal Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Female
Genital Diseases, Male
Genital Neoplasms, Female
Genital Neoplasms, Male
Gonadal Disorders
Intestinal Diseases
Intestinal Neoplasms
Kidney Diseases
Kidney Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on November 25, 2014