NCT05821231

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	SBRT + MEDI5752	SBRT (5 fractions of 10 Gy every two or three days) will be delivered to one lung metastasis (12 days maximum) in combination with MEDI5752\* administered intravenously. The first dose of MEDI5752 will be administered on the day of the last SBRT fraction, then every 3 weeks for up to a maximum of 12 months. \* Dosing 500 mg or 750 mg, according to the recommended dose determined during the dose exploration phase

Timeline

• Start date: 2023-12-12
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2023-04-20
• Last updated: 2025-07-31

Locations

5 sites across 1 country: France