Clinical Trial

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

Study acronym: MEDISARC-SBRT
Active, Not Recruiting Phase 1
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Summary
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2023-04-07; most recent amendment 2025-07-28.
Status change: Recruiting → Active, Not Recruiting 2025-07-28
Status change: Not Yet Recruiting → Recruiting 2023-10-11
Trial Details
NCT Number NCT05821231
Lead Sponsor Institut Claudius Regaud
Collaborators: National Cancer Institute, France, AstraZeneca
Conditions Soft Tissue Sarcoma
Enrollment 20 participants
Start Date 2023-12-12
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2025-07-31