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A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02055066
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
argenx BVBA

Brief Summary:
This a first-in-human study of an antibody blocking the function of the oncogene c-met in patients with cancer.

Condition or disease Intervention/treatment Phase
Cancer Drug: ARGX-111 Phase 1

Detailed Description:
This Phase 1b trial will characterize the safety profile of ARGX 111 and will thus provide the first elements towards establishing an accurate risk-benefit assessment for ARGX 111 in cancer patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer Over-expressing the c-Met Protein.
Study Start Date : January 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: Arm 1
ARGX-111 0.3 mg/kg
Drug: ARGX-111
Experimental: Arm 2
ARGX-111 1.0 mg/kg
Drug: ARGX-111
Experimental: Arm 3
ARGX-111 3.0 mg/kg
Drug: ARGX-111
Experimental: Arm 4
ARGX-111 10 mg/kg
Drug: ARGX-111



Primary Outcome Measures :
  1. Dose-limiting toxicity [ Time Frame: 1 month ]
    Number of patients with grade 3 or 4 toxicity


Secondary Outcome Measures :
  1. Pharmacokinetic profiles (Cmax , Ctrough, AUC, Vd , clearance, and half-life) [ Time Frame: C1 D1 (pre, 0h, 2h, 6h, 12h, 24h), C1D8, C1D15; Cycle ≥2 o D1 pre-/post-dose ]
    Measurement of drug concentration in the blood

  2. Biomarkers (Hepatocyte growth factor; ADCC) [ Time Frame: Base-line and pre-dose at each cycle for an average of 4 months ]
    measurements of cytokine changes in blood as a result of drug administration

  3. Incidence of adverse events per dose level [ Time Frame: for an average of 4 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent.
  2. Age ≥ 18 years.
  3. Performance status of 0 or 1.
  4. Histological diagnosis of malignancy.
  5. Cancer relapsing after, or refractory to standard therapy.
  6. Malignancy over-expressing the c Met protein.
  7. Presence of circulating tumor cells (CTCs).
  8. At least one tumor lesion > 2 cm on PET/CT.
  9. Serum albumin > 35 g/L.
  10. Absolute neutrophil count (ANC) > 1.0 x 109/L.
  11. Hemoglobin > 90 g/L (0.9 g/dL).
  12. Platelet count ≥ 75 x 109/L.
  13. Coagulation parameters ≤ 1.5 x ULN.
  14. Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
  15. Creatine Phosphokinase (CPK) ≤ 2.5 x ULN.
  16. Serum creatinine ≤ 1.5 x ULN.
  17. Ability to comply with protocol-specified procedures/evaluations and scheduled visits.

Exclusion Criteria:

  1. History or clinical evidence of neoplastic central nervous system (CNS) involvement.
  2. Major surgery within 4 weeks of ARGX 111 first dose administration.
  3. Systemic glucocorticoid administration at doses greater than physiological replacement (prednisone 20 mg equivalent) within 3 weeks of ARGX 111 first dose administration.
  4. Cytotoxic chemotherapy within 3 weeks of ARGX 111 first dose administration.
  5. Radiation therapy with curative intent within 3 weeks of ARGX 111 first dose administration.
  6. Biological therapy (monoclonal antibodies) within 4 weeks of ARGX 111 first dose administration.
  7. Biological therapy (other than monoclonal antibodies) within 5 half-lives of ARGX 111 first dose administration.
  8. Unresolved Grade 3 or 4 toxicity from prior therapy, including experimental therapy.
  9. History of recurrent Grade 3 or 4 toxicity from anti c Met therapy.
  10. Uncontrolled diabetes, defined as fasting glycemia > 150 mg/dl).
  11. Active, untreated viral, bacterial, or systemic fungal infection.
  12. Any clinical finding, including psychiatric and behavioral problems, which, in the opinion of the Investigator, precludes the patient from safely participating in the study.
  13. Childbearing potential (unless using an adequate measure of contraception).
  14. Pregnancy or lactation.
  15. History of severe (Grade 3 or 4) hypersensitivity to recombinant proteins.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055066


Locations
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Belgium
Universitair Zieckenhuis Antwerpen
Antwerp, Belgium
Institut Jules Bordet
Brussels, Belgium
Sponsors and Collaborators
argenx BVBA
Investigators
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Principal Investigator: Ahmad Awada, MD Jules Bordet Institute

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Responsible Party: argenx BVBA
ClinicalTrials.gov Identifier: NCT02055066    
Other Study ID Numbers: ARGX-111-1301
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017
Keywords provided by argenx BVBA:
cancer
c-MET