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Phase 1/2 Study of ARGX-110 in Patients With Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT01813539
Recruitment Status : Active, not recruiting
First Posted : March 19, 2013
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
argenx BVBA

Brief Summary:
The purpose of this study is to determine the recommended Phase 2 dose of ARGX-110, an antibody that binds CD70, in patients with advanced malignancies.

Condition or disease Intervention/treatment Phase
Advanced Cancers Drug: ARGX-110 Phase 1 Phase 2

Detailed Description:

Phase I study conducted in patients whose tumors express the target of interest. PK, PD, biomarkers will be determined to support dose selection.

Phase II study conducted in CTCL patients who are CD70 positive. PK, PD, biomarkers and IHC will be determined to assess efficacy


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of ARGX-110 in Patients With Advanced Malignancies Expressing CD70.
Study Start Date : February 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Cohort 1
Dose level 1 : ARGX-110 intravenous administration every 3 weeks. No dose escalation.
Drug: ARGX-110
Outpatient intravenous infusion, in step-wise increments, every 3 weeks.

Experimental: Cohort 2
Dose level 2: ARGX-110 intravenous administration every 3 weeks. No dose escalation.
Drug: ARGX-110
Outpatient intravenous infusion, in step-wise increments, every 3 weeks.

Experimental: Cohort 3
Dose level 3: ARGX-110 intravenous administration every 3 weeks. No dose escalation.
Drug: ARGX-110
Outpatient intravenous infusion, in step-wise increments, every 3 weeks.

Experimental: Cohort 4
Dose level 4: ARGX-110 intravenous administration every 3 weeks. No dose escalation.
Drug: ARGX-110
Outpatient intravenous infusion, in step-wise increments, every 3 weeks.

Experimental: Cohort 5
CTCL patients treated with dose level as cohort 1 and 2.
Drug: ARGX-110
Outpatient intravenous infusion, in step-wise increments, every 3 weeks.




Primary Outcome Measures :
  1. Determine optimal dose of ARGX-110 in patients with advanced malignancies by number of patients with dose-limiting toxicity [ Time Frame: 2 years ]
    DLT defined as drug-related grade 3 or 4 Adverse Events (CTCAE criteria version 4)


Secondary Outcome Measures :
  1. Incidence of AE by dose level [ Time Frame: 2 years ]
    Adverse Events classified according to CTCAE Version 4.

  2. Plasma concentrations of ARGX-110 [ Time Frame: 2 years ]
    ARGX-110 blood levels will be measured using a validated method.

  3. Biomarkers of ARGX-110 biological activity [ Time Frame: 2 years ]
    Biomarkers will be measured in serum and on tumor samples to correlate systemic drug effects with AE and Tumor response.

  4. Number of patients who achieve a tumor response [ Time Frame: 2 years ]
    Response will be assessed according to RECIST.



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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:

  • Age ≥18 years.
  • Written informed consent prior to any study-related procedure, willing and able to comply with protocol-specified procedures and scheduled evaluations.
  • Histological diagnosis of CD70 antigen positive malignancies refractory to, or relapsing after standard therapy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Adequate haematological, hepatic, and renal function (absolute neutrophil count (ANC) > 1.0 x 109/L; haemoglobin > 90 g/L; platelet count ≥ 75 x 109/L; total bilirubin ≤ 1.5 x the upper limit of normal [ULN]; alanine transaminase [ALT] ≤ 3 x ULN or ≤ 5 x ULN for patients with liver metastases; serum creatinine ≤ 1.5 x the ULN).

Exclusion Criteria:

  • Prior allogeneic bone marrow transplantation.
  • History or clinical evidence of neoplastic central nervous system (CNS) involvement.
  • History of another primary malignancy that has not been in remission for at least 1 year.
  • Systemic glucocorticoid administration at doses greater than physiological replacement within 4 weeks of ARGX-110 first dose administration.
  • Major surgery within 4 weeks of ARGX-110 first dose administration.
  • Prior chemotherapy, biological therapy, radiation therapy with curative intent, or any experimental therapy within 4 weeks of ARGX-110 first dose administration.
  • Unresolved grade 3 or 4 toxicity from prior therapy, including experimental therapy.
  • Active, untreated viral, bacterial, or systemic fungal infection.
  • History of human immunodeficiency virus (HIV) infection, persistent hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV) infection.
  • Any clinical finding, including psychiatric and behavioral problems, which, in the opinion of the Investigator, precludes the patient from safely participating in the study.
  • Childbearing potential unless using an adequate measure of contraception.
  • Pregnancy or lactation.
  • History of 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): NCT01813539


Locations
Belgium
UZA - Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
Institut Jules Bordet
Bruxelles, Belgium
UZG - Universitair Ziekenhuis Gent
Gent, Belgium
France
CHU
Bordeaux, France
CHRU
Lille, France
CHLS
Lyon, France
Institut Gustave-roussy
Paris, France
St Louis Hospital
Paris, France
Italy
Institute of Hematology "L. e A. Seràgnoli"
Bologna, Italy
Sponsors and Collaborators
argenx BVBA
Investigators
Principal Investigator: Ahmad Awada, MD Jules Bordet Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: argenx BVBA
ClinicalTrials.gov Identifier: NCT01813539     History of Changes
Other Study ID Numbers: ARGX-110-1201
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Keywords provided by argenx BVBA:
malignancy

Additional relevant MeSH terms:
Neoplasms