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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by ARMO BioSciences
Sponsor:
Information provided by (Responsible Party):
ARMO BioSciences
ClinicalTrials.gov Identifier:
NCT02009449
First received: December 2, 2013
Last updated: March 24, 2015
Last verified: March 2015
  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: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Drug: gemcitabine/nab-paclitaxel
Drug: Capecitabine
Drug: Pazopanib
Drug: Pembrolizumab
Drug: Paclitaxel
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 2015
Estimated Primary Completion Date: December 2015 (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 1
at least 15 RCC 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
Day 1 of every 21 day cycle
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
Day 1 of every 21 day cycle
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
Day 1 of every 21 day cycle
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
Day 1 of every 21 day cycle
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
Day 1 of every 21 day cycle
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: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Intravenous administration on Day 1 and 2 of every 14 day cycle
Other Name: Eloxatin®/Leucovorin/5-FU
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: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Intravenous administration on Day 1 and 2 of every 14 day cycle
Other Name: Eloxatin®/Leucovorin/5-FU
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: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Intravenous administration on Day 1 and 2 of every 14 day cycle
Other Name: Eloxatin®/Leucovorin/5-FU
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: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Intravenous administration on Day 1 and 2 of every 14 day cycle
Other Name: Eloxatin®/Leucovorin/5-FU
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: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Intravenous administration on Day 1 and 2 of every 14 day cycle
Other Name: Eloxatin®/Leucovorin/5-FU
Experimental: Part D: Dose Escalation Cohort 1

AM0010 (5 ug/kg) daily subcutaneous injections with Gemcitabine and nab-paclitaxel on Days 1, 8, 15 of each cycle (28 days = 1 cycle).

Nab-paclitaxel 125 mg/m2 IV over 30 minutes followed by

• Gemcitabine 1000 mg/m2 IV.

Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: gemcitabine/nab-paclitaxel
Intravenous administration of the gemcitabine/nab-paclitaxel regimen on Day 1, 8 and 15 of each 28 day treatment cycle.
Other Name: Gemzar/Abraxane ABI-007
Experimental: Part E: Dose Escalation Cohort 1

AM0010 (10 ug/kg) daily subcutaneous injections with capecitabine BID daily for 14 days of each cycle (21 days= 1 cycle).

• Capecitabine 1000 mg/m2 po BID

Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Capecitabine
Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
Other Name: Xeloda
Experimental: Part F: Dose Escalation Cohort 1

AM0010 (10 ug/kg) daily subcutaneous injections with paclitaxel on Days 1, 8, 15 of each cycle (28 days= 1 cycle)

• Paclitaxel 80 mg/ 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

Paclitaxel will be administered intravenously on Days 1, 8, 15 of each cycle (28 days= 1 cycle)

• Paclitaxel 80 mg/ m2 IV

Other Name: Paclitaxel
Experimental: Part G: Dose Escalation Cohort 1

AM0010 (10 ug/kg) daily subcutaneous injections with pazopanib orally given daily for 14 days of each cycle (21 days= 1 cycle)

• Pazopanib 800 mg po QD

Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Pazopanib
Pazopanib will be administered orally daily continuously
Other Name: GW786034
Experimental: Part H: Dose Escalation Cohort 1

AM0010 (10 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle).

• Pembrolizumab 2 mg/kg IV over 30 min

Drug: AM0010
Daily subcutaneous injections of AM0010 up to 12 months
Other Names:
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Pembrolizumab
Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
Other Name: Keytruda, MK-3475

  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, California
UCLA Medical Hematology & Oncology Recruiting
Los Angeles, California, United States, 90024
Contact: Liz Seja    310-794-6892      
United States, Colorado
Sarah Cannon Research Institute at HealthONE Recruiting
Denver, Colorado, United States, 80218
Contact: Brian Herrick       brian.herrick@healthonecares.com   
Principal Investigator: Gerald Falchook         
United States, Florida
Florida Cancer Specialists & Research Institute Recruiting
Sarasota, Florida, United States, 34232
Contact: Amy Akins       aakins@flcancer.com   
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, Oklahoma
Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kimberly Benjamin    405-271-8778    kimberly-Benjamin@ouhsc.edu   
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
The University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Aung Naing    713-563-1930      
Principal Investigator: Naing Aung, MD         
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: March 24, 2015
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
Lung Neoplasms
Pancreatic Neoplasms
Adenocarcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Kidney Diseases
Kidney Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Capecitabine
Carboplatin
Cisplatin
Docetaxel

ClinicalTrials.gov processed this record on May 21, 2015