Date: 2015-02-17
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Seattle Genetics (USA - WA)
Product: SEA-CD40
Action
mechanism: monoclonal antibody. Seattle Genetics' proprietary SEA technology is a novel approach to increase the potency of monoclonal antibodies. SEA technology produces a non-fucosylated monoclonal antibody, resulting in an enhanced innate immune response. SEA-CD40 represents the first clinical antibody employing the SEA technology. Enhanced binding to effector cells results in better crosslinking and activation of CD40 signaling in immune cells. This stimulation of the patient’s own immune cells has the potential to result in antitumor activity. Preclinical studies show that the non-fucosylated antibody is a potent stimulator of immune cells that may be able to harness the power of a patients’ immune system to fight cancer. SEA-CD40 is targeted to CD40, a widely expressed stimulatory receptor found on antigen-presenting cells (APCs) which play a role in immune cell activation.
Disease: advanced solid tumors
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This phase I study will examine the safety profile of SEA-CD40. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated. (NCT02376699)
Latest
news: * On February 17, 2015, Seattle Genetics announced initiation of a phase 1 clinical trial of SEA-CD40 for multiple types of advanced solid tumors. SEA-CD40 is a novel investigational immuno-oncology agent targeted to CD40, a widely expressed stimulatory receptor found on antigen-presenting cells (APCs) which play a role in immune cell activation. SEA-CD40 utilizes Seattle Genetics’ proprietary sugar-engineered antibody (SEA) technology to produce a non-fucosylated antibody targeting CD40. Preclinical data show that SEA-CD40 stimulates the immune system to fight cancer. The study is a phase 1, open-label, multi-center, dose-escalation clinical trial of SEA-CD40 in patients with advanced solid tumors who have failed current standard of care treatments. Expansion cohorts are planned to evaluate SEA-CD40 across up to three cancer indications that will be determined based on data from the dose escalation portion of the study. The primary endpoints are determination of the maximum tolerated dose (MTD) and safety profile of SEA-CD40. In addition, the trial will evaluate antitumor activity, pharmacokinetics and immunological pharmacodynamic effects. The phase 1 trial will enroll approximately 50 patients during dose escalation and up to 90 patients in the expansion cohorts at multiple centers in the United States.
