Study Evaluating the Safety and Efficacy of MEDI5752 in Combination With Stereotactic Radiotherapy in Patients With Metastatic Sarcoma

연구 개요

This is a phase I, multicenter, open-label study starting with a dose exploration phase and followed by an expansion phase to evaluate the safety profile and the preliminary activity of the bispecific antibody anti PD-1/CTLA-4 MEDI5752 in combination with SBRT delivered on one lung metastatic lesion, in patients with metastatic soft tissue sarcoma. Dose exploration phase: The primary objective of this dose exploration phase I trial is to determine the Maximum Tolerated Dose and the toxicity profile of MEDI5752 when administrated with stereotactic radiotherapy in patients with metastatic sarcoma with lung metastases. Expansion phase: The primary objective of the expansion phase is to investigate preliminary activity of MEDI5752 when administrated with stereotactic radiotherapy in patients with metastatic sarcoma with lung metastases. A maximum of 20 evaluable patients will be included in this trial.