August 26 2020
Byondis B.V. (formerly Synthon Biopharmaceuticals B.V.) today announced that the first patients have started treatment in a Phase I study of its investigational antibody-drug conjugate (ADC) [vic-]trastuzumab duocarmazine (SYD985) in combination with niraparib in patients with a HER2-expressing locally advanced or metastatic solid tumor.
A Two-part Phase I Study With the Antibody-drug Conjugate SYD985 in Combination With Niraparib to Evaluate Safety, Pharmacokinetics and Efficacy in Patients With HER2-expressing Locally Advanced or Metastatic Solid Tumors (SYD985.004) will enroll up to 120 patients who progressed on standard therapy or for whom no standard therapy of proven benefit exists. The first part of the study is taking place in leading European oncology centers in Belgium, United Kingdom and the Netherlands. Leading centers in France, Spain and Poland will join this trial at a later stage.
“We are excited to move to the clinical study phase of [vic-]trastuzumab duocarmazine in combination with PARP inhibitor niraparib,” said Byondis CEO Marco Timmers, Ph.D. “Preclinical investigation of SYD985 in combination with PARP inhibitors in HER2-expressing tumor cells suggested synergistic effects and we hope to confirm these effects in the clinic.”
SYD985 is Byondis’ most advanced ADC, in development for the treatment of a range of HER2-expressing tumor types including breast and endometrial cancer. Previously, the U.S. Food & Drug Administration granted SYD985 fast track designation based on promising data from heavily pre-treated last-line HER2-positive metastatic breast cancer patients participating in a two-part Phase I clinical study (SYD985.001). The pivotal Phase III TULIP® study (SYD985.002) comparing the efficacy and safety of SYD985 to physician's choice treatment in patients with HER2-positive unresectable locally advanced or metastatic breast cancer is ongoing. In addition, Byondis recently announced the start of a Phase II study (SYD985.003) evaluating the safety and efficacy of SYD985 in patients with HER2-expressing recurrent, advanced or metastatic endometrial (uterine) cancer.
More About SYD985.004
SYD985.004 will explore the preclinically proven synergistic anti-tumor effects of the SYD985 and niraparib combination, which may result in increased efficacy. As both drugs will be given at lower doses than when applied as single agents, this could coincide with reduced toxicity. The study’s primary endpoint is dose-limiting toxicities in the first cycle (21 days). Secondary objectives include overall safety, pharmacokinetic and preliminary efficacy assessments for the combination treatment.
SYD985.004 wil...
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