The gist: A clinical trial has begun to test a new treatment for people with HER2-positive breast cancer. The drug is called SYD985. It is being tested in people with locally advanced or metastatic tumors. The first phase of testing will enroll both HER2-positive and HER2-negative cancer patients to test the safety of the drug. The second phase will enroll HER2-positive breast and gastric cancer patients, including patients with low expression of HER2 (HER2 2+).
“Synthon Biopharmaceuticals (‘Synthon’) today announced that the first patients with metastatic solid tumors have commenced treatment with its investigational anti-HER2 antibody-drug conjugate (ADC), SYD985.
“First patients for this trial are being enrolled in leading European oncology centers Radboud University Medical Center (Nijmegen, the Netherlands), the Jules Bordet Institute (Brussels, Belgium) and the Institute of Cancer Research at The Royal Marsden Hospital (London, United Kingdom). The trial will recruit at least 76 patients and more centers are expected to join the trial in 2015.
“This trial is a two part first-in-human Phase I study. In the dose escalation part of the trial, safety and efficacy of SYD985 will be evaluated in patients with locally advanced or metastatic solid tumors of any origin. In the expanded cohort part of the trial, only patients with breast and gastric cancer will be enrolled. The expanded cohorts will include patients currently indicated for HER2-targeted treatment as well as patients with HER2 2+ and HER2 1+ breast cancer for whom there currently is no effective anti-HER2 therapy available.”