Date: 2014-11-11
Type of information: Initiation of the trial
phase: 1b
Announcement: initiation of the trial
Company: Argen-X (Belgium)
Product: ARGX-110
Action
mechanism: monoclonal antibody/immune checkpoint inhibitor. ARGX-110 is a SIMPLE antibody™ targeting CD70, an immune checkpoint target involved in hematological malignancies (lymphomas and leukemias), several solid tumors and autoimmune diseases. ARGX-110 works in three ways: i) blocks growth of tumor cells, ii) kills cancer cells and iii) activates the patients’ immune system against the tumor.
Disease: patients with relapsed/refractory CD70-positive T-cell lymphomas
Therapeutic area: Cancer - Oncology
Country: Belgium, France
Trial
details: The Phase 1b study with ARGX-110 consists of a dose-escalation phase followed by adaptive safety and efficacy expansion cohorts, one in solid tumors and one in hematological cancers, conducted in patients with advanced, refractory cancer. Data from the study will be used to select one or more indications for further clinical investigations.
The patient enrichment strategy relies on individual tumor screening for CD70 utilizing a validated immunohistochemistry method. In addition to traditional clinical and PK/PD endpoints, biomarkers documenting the three modes of action of ARGX-110 are being evaluated. Patient enrolment is planned at approximately 60 CD70-positive patients with either hematological or solid tumors. The study is managed jointly by arGEN-X and a consortium of leading academic institutions in Europe. (NCT01813539)
Latest
news: * On November 11, 2014, arGEN-X, a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, announced that it has initiated a clinical efficacy evaluation of ARGX-110, its investigational anti-CD70 therapeutic antibody, in patients with relapsed/refractory CD70-positive T-cell lymphomas. The evaluation will be conducted as an expansion arm of the ongoing Phase 1b study of ARGX-110. Up to 30 patients with relapsed/refractory CD70-positive T-cell lymphoma are planned to be enrolled and evaluated. The primary objective is to assess the overall response rate of patients treated with ARGX-110. Secondary objectives include duration of response.
In the initial dose-escalation of the Phase 1b study, ARGX-110 demonstrated a favorable safety profile with no dose-limiting toxicities seen in the 26 patients treated. Encouraging signs of efficacy were also observed, and direct antitumor activity was demonstrated in two patients with T-cell lymphoma, including a complete response (CR) in a patient with Sézary syndrome.
