Phase I study evaluating the safety and efficacy of MEDI5752 in combination with stereotactic radiotherapy in patients with metastatic sarcoma

Phase 1

Active, not recruiting

• Conditions: Metastatic soft tissue sarcoma

• Registration Number: 2024-515551-38-00
• Lead Sponsor: Oncopole Claudius Regaud

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-07
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-20
• Study Start: 2023-12-12
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-31
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Dose exploration Phase: The incidence of the Dose-limiting toxicity (DLT)	6 weeks after the last dose of radiotherapy for each patient	For each patient, DLT incidence will be evaluated during the first cycle.
Expansion phase: the rate of patients alive and without progression at 3 months.	3 months post treatment for each patient

Secondary Outcome Measures

Name	Time	Method
Dose exploration and Expansion Phases: Objective Response Rate (ORR) defined as the rate of patients with an objective response (i.e. CR or PR according to RECIST v1.1 criteria).	15 months for each patient
Dose exploration and Expansion Phases: Progression-Free Survival (PFS) defined (per RECIST v1.1 criteria) as the time from treatment initiation until progression or death from any cause, whichever occurs first.	15 months for each patient
Dose exploration and Expansion Phases: The incidence of Treatment-Emergent Adverse Events will be evaluated using the NCI-CTCAE Version 5.0.	15 months for each patient
Dose exploration and Expansion Phases: Overall Survival (OS) defined as the time from treatment initiation to death from any cause.	15 months for each patient
Dose exploration and Expansion Phases: Time to progression of irradiated lesions defined as the time from treatment initiation until progression of irradiated lesions or death from any cause.	15 months for each patient
Dose exploration and Expansion Phases: Time to progression outside the irradiation field defined as the time from treatment initiation until progression outside the irradiation field or death from any cause.	15 months for each patient

Trial Locations

Locations (5)

Institut Bergonié; 🇫🇷 Bordeaux, France

Institut Regional Du Cancer de Montpellier; 🇫🇷 Montpellier, France

IUCT-O; 🇫🇷 Toulouse, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Leon Berard; 🇫🇷 Lyon, France