Synthon Biopharmaceuticals' most advanced pipeline program is [vic-]trastuzumab duocarmazine (SYD985), an ADC targeting a range of HER2-positive cancers such as (metastatic) breast cancer, gastric cancer, bladder (urothelial) cancer and endometrial (uterine) cancer.
About trial SYD985.002 (Phase III)
Trial SYD985.002 (or TULIP®) is a multi-center, open-label, randomized clinical Trial comparing the efficacy and safety of the antibody-drUg conjugate [vic-]trastuzumab duocarmazine (SYD985) to physician's choice in HER2-positive unresectable Locally advanced or metastatIc breast cancer Patients.
Primary objective is to demonstrate that [vic-]trastuzumab duocarmazine is superior to physician’s choice in prolonging progression-free survival (PFS) on the basis of the blinded independent central review of tumor assessment. Secondary objectives are to compare the two treatment groups with respect to overall survival (OS); objective response rate (ORR) on the basis of the blinded independent central review; Investigator assessed PFS; patient-reported outcomes (PRO) for health related quality of life (EORTC QOL C30 & BR23); safety and tolerability.
This trial is registered in ClinicalTrials.gov with identifier NCT03262935.
About trial SYD985.001
Trial SYD985.001 is a two part first-in-human Phase I study with the anti-HER2 ADC SYD985 to evaluate the safety, pharmacokinetics and efficacy in patients with histologically-confirmed, locally advanced or metastatic tumors. These are patients who have progressed on standard therapy or for whom no standard therapy exists.
During part I (dose escalation), patients with solid tumors of any origin were enrolled (so called 'all comers'). For part II (expanded cohorts), enrollment includes patients with breast or selected non-breast tumors with demonstrated HER2 expression and measurable disease lesions, which are predefined in the protocol. This trial is registered in ClinicalTrials.gov with identifier NCT02277717.
Preclinical Profile of the HER2-Targeting ADC SYD983/SYD985: Introduction of a New Duocarmycin-Based Linker-Drug Platform (Mol. Cancer Therapeutics 2014/11)partner with Synthon Biopharmaceuticals