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Byondis, a pharmaceutical company, announced today that a phase I study of a joint treatment of HER2-positive solid tumor patients with the research antibody-drug association (ADC) and synthesizer monoantigen Duocarmazine (SYD985) and Nirapali has officially begun, with the first patients already in the group.
Phase I study, which will assess the safety, pharmacological dynamics and efficacy of SYD985 in treating HER2-positive patients with locally advanced or metastasis solid tumors, will recruit up to 120 patients.
of the study will be conducted at major oncology centres in Belgium, the UK and the Netherlands.
major research centres in France, Spain and Poland will join the experiment in Part II. Dr Marco Timmers, chief executive of
Byondiss, said: "Preclinical studies have shown that SYD985, in combined with PARP inhibitors, has a synergistic anti-tumor effect on tumor cells that express HER2, and we hope to confirm these effects clinically."
SYD985 is byondis' most advanced ADC and is being developed to treat a variety of tumors that express HER2, including breast and endometrial cancers.
FDA has granted SYD985 fast-track eligibility based on positive results from two Phase I clinical studies.
addition, Byondis recently announced the commment of Phase II clinical studies (SYD985.003) to assess the safety and effectiveness of SYD985 in patients with relapsed, advanced or metastatic endometrial cancer who express HER2.
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