ARGX-110
DrugARGX-110 will be administered as an IV infusion.
NCT Number: NCT01813539
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).
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Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Brussels, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ARGX-110 will be administered as an IV infusion.
Time frame: 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.
Time frame: Up to 2 years
Plasma concentration of ARGX-110 will be assessed.
Time frame: 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.
Time frame: Up to 2 years
Tumor response will be assessed according to RECIST.
OncoVerity, Inc.
Industry
A Phase I/II Study of ARGX-110 in Patients With Advanced Malignancies Expressing CD70.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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