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: 28 Apr 2017
At a glance
- Drugs SYD 985 (Primary)
- Indications Advanced breast cancer; Endometrial cancer; Gastric cancer; Solid tumours; Urogenital cancer
- Focus Adverse reactions; First in man
- Sponsors Synthon
- 13 Oct 2016 Planned primary completion date changed from 1 Jun 2016 to 1 Apr 2017.
- 18 May 2016 Results from dose finding part of the study published in the Synthon Pharmaceuticals media release.
- 18 May 2016 According to a Synthon Pharmaceuticals media release, second part of this study which will evaluate 48 additional heavily pre-treated patients with HER2-positive breast cancer has been initiated. Data from this cohort will enable Synthon to design the first pivotal trial with SYD985 as suggested by several national regulatory authorities and subject to an ongoing EMA scientific advice request regarding the most optimal development pathway.