[vic-]trastuzumab duocarmazine (SYD985)

Synthon's 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.

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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

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)

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