Neoplasms
Conditions
Keywords
Malignancy
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.
Interventions
DRUGARGX-110
ARGX-110 will be administered as an IV infusion.
Sponsors
argenx
Janssen Research & Development, LLC
OncoVerity, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Dose Limiting Toxicity (DLT) | 21 days | DLT is defined as drug-related grade 3 or 4 clinical adverse event (AE) occurring during the 21 days (3 weeks) following the first dose of ARGX-110. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentrations of ARGX-110 | Up to 2 years | Plasma concentration of ARGX-110 will be assessed. |
| Biomarkers (CD70 qPCR and sCD27) of ARGX-110 biological activity | Up to 2 years | Biomarkers (CD70 quantitative polymerase chain reaction \[CD70 qPCR\] and soluble CD27 \[sCD27\]) will be measured in serum and on tumor samples to correlate systemic drug effects with AE and Tumor response. |
| Number of Participants who Achieve a Tumor Response | Up to 2 years | Tumor response will be assessed according to RECIST. |
Countries
Belgium, France
Outcome results
None listed