Phase I Study Evaluating the Safety and Efficacy of MEDI5752 in Combination With Stereotactic Radiotherapy in Patients With Metastatic Sarcoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Oncopole Claudius Regaud
- Enrollment
- 20
- Locations
- 5
- Primary Endpoint
- Dose exploration Phase: The incidence of the Dose-limiting toxicity (DLT)
- Status
- Active, not recruiting
- Last Updated
- 9 months ago
Overview
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.
Investigators
Dr Thibaud VALENTIN
Scientific
Oncopole Claudius Regaud
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Dose exploration Phase: The incidence of the Dose-limiting toxicity (DLT)
Time Frame: 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.
Time Frame: 3 months post treatment for each patient
Secondary Outcomes
- 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)