Clinical trial NCT01813539: A Study of ARGX-110 in Participants With Advanced Malignancies
Official title: A Phase I/II Study of ARGX-110 in Patients With Advanced Malignancies Expressing CD70.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neoplasms
Keywords: Malignancy
Lead sponsor: OncoVerity, Inc.
Sponsor class: INDUSTRY
Collaborators: name: argenx
name: Janssen Research & Development, LLC
First posted: 2013-03-19
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the optimal dose of ARGX-110 in participants with advanced malignancies and to assess efficacy of ARGX-110 (exploratory efficacy cohort 5 only).

Detailed description: Phase I study conducted in participants whose tumors express the target of interest. Pharmacokinetics (PK), pharmacodynamics (PD), biomarkers will be determined to support dose selection.

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.

Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of malignancy refractory to, or relapsing after standard therapy
* 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 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 (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

Primary outcomes:
measure: Number of Participants with Dose Limiting Toxicity (DLT)
timeFrame: 21 days
Secondary outcomes:
measure: Plasma Concentrations of ARGX-110
timeFrame: Up to 2 years
measure: Biomarkers (CD70 qPCR and sCD27) of ARGX-110 biological activity
timeFrame: Up to 2 years
measure: Number of Participants who Achieve a Tumor Response
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Brussel
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Bordeaux
country: France
city: Lille
country: France
city: Paris
country: France
city: Pierre-Bénite
country: France
city: Villejuif
country: France
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.