A Study of ARGX-110 in Participants With Advanced Malignancies
NCT ID: NCT01813539
Last Updated: 2023-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
99 participants
INTERVENTIONAL
2013-02-27
2020-07-10
Brief Summary
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Detailed Description
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Phase II study conducted in Cutaneous T-cell lymphoma (CTCL) participants who are CD70 positive. PK, PD, biomarkers and immunohistochemistry (IHC) will be determined to assess efficacy.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation: Cohort 1
Participants will receive ARGX-110 as an intravenous infusion (IV) at dose level 1.
ARGX-110
ARGX-110 will be administered as an IV infusion.
Dose Escalation: Cohort 2
Participants will receive ARGX-110 as an IV infusion at dose level 2.
ARGX-110
ARGX-110 will be administered as an IV infusion.
Dose Escalation: Cohort 3
Participants will receive ARGX-110 as an IV infusion at dose level 3.
ARGX-110
ARGX-110 will be administered as an IV infusion.
Dose Escalation: Cohort 4
Participants will receive ARGX-110 as an IV infusion at dose level 4.
ARGX-110
ARGX-110 will be administered as an IV infusion.
Dose Escalation: Cohort 5
Participants will receive ARGX-110 as an IV infusion at intermediate dose level at the conclusion of Cohort 4 prior to opening the safety expansion cohorts to participants enrolment.
ARGX-110
ARGX-110 will be administered as an IV infusion.
Safety Expansion: Cohort 1
Participants with solid tumors will receive ARGX-110 as an IV infusion at a dose based on the safety, PD, and PK profiles of ARGX-110 as per the dose escalation part of the trial.
ARGX-110
ARGX-110 will be administered as an IV infusion.
Safety Expansion: Cohort 2
Participants with hematological malignancies (all etiologies) will receive ARGX-110 as an IV infusion at a dose based on the safety, PD, and PK profiles of ARGX-110 as per the dose escalation part of the trial.
ARGX-110
ARGX-110 will be administered as an IV infusion.
Safety Expansion: Cohort 3
Participants with cutaneous T-cell lymphoma (CTCL) will receive ARGX-110 as an IV infusion at dose level 2 followed by a maintenance therapy at dose level 2 or 3.
ARGX-110
ARGX-110 will be administered as an IV infusion.
Safety Expansion: Cohort 4
Participants with peripheral T-cell lymphoma (PTCL) will receive ARGX-110 as an IV infusion at dose level 2 followed by a maintenance therapy at dose level 2 or 3.
ARGX-110
ARGX-110 will be administered as an IV infusion.
Exploratory Efficacy: Cohort 5
Participants with relapsed/refractory CTCL will receive ARGX-110 as an IV infusion followed by a maintenance therapy at dose level 3.
ARGX-110
ARGX-110 will be administered as an IV infusion.
Interventions
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ARGX-110
ARGX-110 will be administered as an IV infusion.
Eligibility Criteria
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Inclusion Criteria
* Solid tumors or T-cell malignancies positive for the CD70 antigen by Immunohistochemistry/Fluorescence-activated cell sorting (IHC/FACS) within 56 days prior to administering the first dose of ARGX-110. IHC criterion: greater than \> 10 percent (%) of CD70 positive tumor cells
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or 2
* Serum albumin greater than or equal to (\>=) 20 gram per liter (g/L) (solid tumor only)
* Ability to comply with protocol-specified procedures/evaluations and scheduled visits. In particular, the ability of the patient to undergo a tumor biopsy (optional for safety expansion cohort 4)
Exclusion Criteria
* 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 (prednisolone 20 milligram \[mg\] equivalent) within 28 days of ARGX-110 first dose administration (for T-cell malignancies higher systemic dose can be allowed following discussion with Sponsor)
* Major surgery within 28 days of ARGX-110 first dose administration
* Unresolved grade 3 or 4 toxicity from prior therapy, including experimental therapy
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Janssen Research & Development, LLC
INDUSTRY
OncoVerity, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Brussels, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Bordeaux, , France
Lille, , France
Paris, , France
Pierre-Bénite, , France
Villejuif, , France
Countries
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References
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Silence K, Dreier T, Moshir M, Ulrichts P, Gabriels SM, Saunders M, Wajant H, Brouckaert P, Huyghe L, Van Hauwermeiren T, Thibault A, De Haard HJ. ARGX-110, a highly potent antibody targeting CD70, eliminates tumors via both enhanced ADCC and immune checkpoint blockade. MAbs. 2014 Mar-Apr;6(2):523-32. doi: 10.4161/mabs.27398. Epub 2013 Dec 6.
Other Identifiers
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ARGX-110-1201
Identifier Type: OTHER
Identifier Source: secondary_id
2012-005046-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR108755
Identifier Type: -
Identifier Source: org_study_id
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