Nanobiotix, a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, announced that it has completed patient inclusion for the phase II/III trial (Act.In.Sarc) of its lead product candidate, NBTXR3, in soft tissue sarcoma. The last patients are expected to start their treatment in two to three weeks.
Elsa Borghi, Nanobiotix's chief medical officer commented: "We are pleased to have reached this important milestone in Nanobiotix's soft tissue sarcoma study, and we look forward to reporting our first data next year."
The pivotal international phase II/III study in soft tissue sarcoma was launched in Europe and Asia in October 2014 and aims to evaluate the safety and the efficacy of NBTXR3, a first-in-class radio-enhancer that could potentially target most solid tumors. The phase II/III study is a prospective, randomized, multi-center, open label and active controlled two-arm study of 156 patients with locally advanced soft tissue sarcoma.
The trial's primary endpoint is the complete pathological response rate. The secondary endpoints are the objective response rate (ORR) by imaging (MRI); the evaluation of the safety profile in terms of clinical and laboratory adverse events; the tumor volume changes; the resection margins and the limb amputation rate. Furthermore, an exploratory analysis of the progression free survival is planned once the follow-up period has been completed for all treated patients.
Nanobiotix expects to present the results of its phase II/III trial in soft tissue sarcoma in the first half of 2018.
Nanobiotix completes patient, soft tissue sarcoma
