Date: 2017-01-05
Type of information: Recruitment of the first patient
phase: 1
Announcement: recruitment of the first patient
Company: Seattle Genetics (USA - WA)
Product: SGN-CD352A
Action
mechanism: antibody drug conjugate (ADC). SGN-CD352A is a novel investigational ADC targeted to CD352 utilizing Seattle Genetics’ proprietary ADC technology. CD352 is broadly expressed on B-cell cancers including multiple myeloma, chronic lymphocytic leukemia, and non-Hodgkin lymphoma, while exhibiting low expression on normal white blood cells. The CD352 engineered cysteine antibody is stably linked to a highly potent DNA binding agent called a pyrrolobenzodiazepine (PBD) dimer via site-specific conjugation technology (EC-mAb). PBD dimers are significantly more potent than systemic chemotherapeutic drugs and the EC-mAb technology allows uniform drug-loading onto an ADC. Preclinical SGN-CD352A data presented at the 2016 American Association of Cancer Research (AACR) Annual Meeting demonstrated that SGN-CD352A specifically binds to target cells and induces potent antitumor activity in both multiple myeloma and non-Hodgkin lymphoma disease models. In addition to being a potential new monotherapy for multiple myeloma, the tolerability profile from preclinical results suggests that SGN-CD352A may be combined with current standard of care treatments for multiple myeloma.
Disease: multiple myeloma
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This study tests the safety of SGN-CD352A, to find out what its side effects are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple myeloma. (NCT02954796)
Latest
news: * On January 5, 2017, Seattle Genetics announced enrollment of the first patient in a multicenter phase 1 clinical trial of SGN-CD352A for patients with relapsed or refractory multiple myeloma. The trial is designed to assess the safety and antitumor activity of SGN-CD352A. This study represents Seattle Genetics’ first clinical-stage ADC program in development for multiple myeloma. The phase 1, open-label multicenter clinical study is designed to evaluate the safety and preliminary antitumor activity of SGN-CD352A as a single agent in adults with relapsed or refractory multiple myeloma. The trial will be conducted in two parts, with a dose escalation part to identify the maximum tolerated dose of SGN-CD352A followed by an expansion part to further define safety and antitumor activity. SGN-CD352A will be administered every four weeks, and the study will enroll approximately 75 relapsed or refractory patients at multiple centers in the United States.
