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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ARMO BioSciences
ClinicalTrials.gov Identifier:
NCT02009449
First received: December 2, 2013
Last updated: March 13, 2017
Last verified: February 2017
  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 or immunotherapy.

Condition Intervention Phase
Melanoma Prostate Cancer Ovarian Cancer Renal Cell Carcinoma Colorectal Carcinoma Pancreatic Carcinoma Non-small Cell Lung Carcinoma Solid Tumors Breast Cancer 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 Drug: nivolumab Drug: Gemcitabine/carboplatin Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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, Preliminary Clinical Activity 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 ]
  • Pharmacokinetic (PK) parameters [ Time Frame: up to 12 months ]
    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 ]
  • 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 ]
  • Anti-AM0010 antibody formation [ Time Frame: up to 12 months ]

Enrollment: 350
Study Start Date: November 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: February 2018 (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 22 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 22 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 22 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 22 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 22 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 22 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 22 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
Other Name: Taxol or taxotere and paraplatin or platinol
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
Other Name: Taxol or taxotere and paraplatin or platinol
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
Other Name: Taxol or taxotere and paraplatin or platinol
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
Other Name: Taxol or taxotere and paraplatin or platinol
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 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

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
Experimental: Part I: Dose Escalation Cohort 1

AM0010 (20 ug/kg) daily subcutaneous injections with nivolumab on Day 1 of each cycle (14 days= 1 cycle).

• Nivolumab 3 mg/kg IV over 60 min

Drug: nivolumab
Nivolumab on Day 1 of each cycle (14 days = 1 cycle)
Other Name: Keytruda
Experimental: Part H: Dose Escalation Cohort 2

AM0010 (20 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: Pembrolizumab
Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
Other Name: Keytruda, MK-3475
Experimental: Part H: Dose Escalation Cohort 3

AM0010 (40 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: Pembrolizumab
Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
Other Name: Keytruda, MK-3475
Experimental: Part J: Dose Escalation Cohort 1
AM0010 (10 ug/kg) daily subcutaneous injections with gemcitabine and carbolplatin on Days 1,8 of each cycle (21 days=1 cycle) until disease progression gemcitabine 1000mg/m2 IV over 30 minutes followed by carboplatin AUC2 over 60 minutes
Drug: Gemcitabine/carboplatin
gemcitabine and carboplatin on Days 1, 8 of each cycle (21 days = 1 cycle)
Other Name: gemzar/paraplatin

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Los Angeles, California, United States, 90024
UCSF
San Francisco, California, United States
United States, Colorado
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
United States, Florida
Florida Cancer Specialists & Research Institute
Sarasota, Florida, United States, 34232
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Oklahoma
Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
ARMO BioSciences
Investigators
Study Director: Martin Oft, MD ARMO
  More Information

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 13, 2017

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

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

ClinicalTrials.gov processed this record on September 21, 2017