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

December 2, 2013
March 24, 2015
November 2013
December 2015   (final data collection date for primary outcome measure)
  • 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).
  • 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).
Complete list of historical versions of study NCT02009449 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Phase 1 Study of AM0010 in Patients With Advanced Solid Tumors
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Melanoma
  • Prostate Cancer
  • Ovarian Cancer
  • Renal Cell Carcinoma
  • Colorectal Carcinoma
  • Pancreatic Carcinoma
  • Non-small Cell Lung Carcinoma
  • Solid Tumors
  • 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
  • Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
    Intravenous administration on Day 1 and 2 of every 14 day cycle
    Other Name: Eloxatin®/Leucovorin/5-FU
  • 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
  • Drug: Capecitabine
    Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
    Other Name: Xeloda
  • Drug: Pazopanib
    Pazopanib will be administered orally daily continuously
    Other Name: GW786034
  • Drug: Pembrolizumab
    Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
    Other Name: Keytruda, MK-3475
  • 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 A: Dose Escalation Cohort 1
    AM0010 (1 ug/kg) - Daily subcutaneous (SC) injections of AM0010 for up to 12 months
    Intervention: Drug: AM0010
  • Experimental: Part A: Dose Escalation Cohort 2
    AM0010 (2.5 ug/kg) - Daily subcutaneous injections of AM0010 for up to 12 months
    Intervention: Drug: AM0010
  • Experimental: Part A: Dose Escalation Cohort 3
    AM0010 (5 ug/kg) - Daily subcutaneous injections of AM0010 for up to 12 months
    Intervention: Drug: AM0010
  • Experimental: Part A: Dose Escalation Cohort 4
    AM0010 (10 ug/kg) - Daily subcutaneous injections of AM0010 for up to 12 months
    Intervention: Drug: AM0010
  • Experimental: Part A: Dose Escalation Cohort 5
    AM0010 (20 ug/kg) - Daily subcutaneous injections of AM0010 for up to 12 months
    Intervention: Drug: AM0010
  • Experimental: Part A: Dose Escalation Cohort 6
    AM0010 (40 ug/kg) - Daily subcutaneous injections of AM0010 for up to 12 months
    Intervention: Drug: AM0010
  • Experimental: Part A: Dose Expansion Cohort 1
    at least 15 RCC patients will be dosed with AM0010 for up to 12 months
    Intervention: Drug: AM0010
  • 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
    Interventions:
    • Drug: AM0010
    • 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
    Interventions:
    • Drug: AM0010
    • 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
    Interventions:
    • Drug: AM0010
    • 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
    Interventions:
    • Drug: AM0010
    • 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
    Interventions:
    • Drug: AM0010
    • 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
    Interventions:
    • Drug: AM0010
    • Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
  • 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
    Interventions:
    • Drug: AM0010
    • Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
  • 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
    Interventions:
    • Drug: AM0010
    • Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
  • 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
    Interventions:
    • Drug: AM0010
    • Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
  • 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
    Interventions:
    • Drug: AM0010
    • Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
  • 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.

    Interventions:
    • Drug: AM0010
    • Drug: gemcitabine/nab-paclitaxel
  • 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

    Interventions:
    • Drug: AM0010
    • Drug: Capecitabine
  • 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

    Interventions:
    • Drug: AM0010
    • Drug: 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

    Interventions:
    • Drug: AM0010
    • Drug: Pazopanib
  • 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

    Interventions:
    • Drug: AM0010
    • Drug: Pembrolizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
135
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT02009449
AM0010-001
No
ARMO BioSciences
ARMO BioSciences
Not Provided
Study Director: Martin Oft, MD ARMO
ARMO BioSciences
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP