[vic-]trastuzumab duocarmazine (SYD985)

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.

If you have any questions, please contact us

SYD985 data shared

The encouraging clinical results obtained in the first (dose-escalation) part of the clinical trial with SYD985 were presented at several renowned venues.

Scientific publications

Trastuzumab duocarmazine in locally advanced and metastatic solid tumours and HER2-expressing breast cancer: a phase 1 dose-escalation and dose-expansion study (The Lancet Oncology, 2019/06)

Unraveling the interaction between carboxylesterase 1c and the antibody-drug conjugate SYD985: improved translational PKPD by using CES1c knockout mice (Mol. Cancer Therapeutics, 2018/8)

SYD985, a Novel Duocarmycin-Based HER2-Targeting Antibody-Drug Conjugate, Shows Antitumor Activity in Uterine Serous Carcinoma with HER2/Neu Expression (Mol. Cancer Therapeutics, 2016/8)

Design, Synthesis, and Evaluation of Linker-Duocarmycin Payloads: Toward Selection of HER2-Targeting Antibody-Drug Conjugate SYD985 (Mol. Pharmaceutics, 2015/12)

The Preclinical Profile of the Duocarmycin-Based HER2-Targeting ADC SYD985 Predicts for Clinical Benefit in Low HER2-Expressing Breast Cancers (Mol. Cancer Therapeutics 2015/3)

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
     Share this page