A Two Part First-in-human Phase I Study (With Expanded Cohorts) With the Antibody-drug Conjugate SYD985 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With Locally Advanced or Metastatic Solid Tumors
Phase of Trial: Phase I
Latest Information Update: 27 Feb 2018
At a glance
- Drugs Trastuzumab-duocarmazine-Synthon-Biopharmaceuticals (Primary)
- Indications Advanced breast cancer; Endometrial cancer; Gastric cancer; Solid tumours; Urogenital cancer
- Focus Adverse reactions; First in man
- Sponsors Synthon
- 27 Feb 2018 Results assessing efficacy and safety of SYD985 in patients with HER2-positive and HER2-negative breast cancer presented at the San Antonio Breast Cancer Symposium in December 2016 : American Association for Cancer Research; Cancer Research.
- 25 Jan 2018 According to a Synthon Pharmaceuticals media release, preliminary results of the trial were presented at the San Antonio Breast Cancer Symposium in December 2016
- 25 Jan 2018 According to a Synthon Pharmaceuticals media release, based on the results of this trial, the US FDA has granted Fast Track designation to trastuzumab duocarmazine (SYD985) for treating patients diagnosed with HER2-positive metastatic breast cancer (MBC) that has progressed during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease, or progressed during or after [ado-]trastuzumab emtansine treatment.