Viewing Study NCT01813539



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Study NCT ID: NCT01813539
Status: COMPLETED
Last Update Posted: 2023-08-09
First Post: 2013-03-07

Brief Title: A Study of ARGX-110 in Participants With Advanced Malignancies
Sponsor: OncoVerity Inc
Organization: OncoVerity Inc

Study Overview

Official Title: A Phase III Study of ARGX-110 in Patients With Advanced Malignancies Expressing CD70
Status: COMPLETED
Status Verified Date: 2023-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
ARGX-110-1201 OTHER None None
2012-005046-38 EUDRACT_NUMBER Janssen Research Development LLC None