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Soft Tissue SarcomaPhase 1MEDISARC-SBRTNCT05821231

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

A Phase 1 study testing SBRT + MEDI5752 in people with Soft Tissue Sarcoma, run by Institut Claudius Regaud at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
SBRT + MEDI5752
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
5 sitesFrance
Study dates
12 Dec 2023to 7 Sep 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed soft tissue sarcoma of following subtype: undifferentiated pleomorphic sarcoma, myxofibrosarcoma, leiomyosarcoma, pleomorphic rhabdomyosarcoma, or pleomorphic liposarcoma
  • Patients with metastatic disease, including (but not restricted to) lung metastasis (in case of lung metastasis only, patients must have more than 5 metastases measurable by RECIST 1.1)
  • Patient with at least two metastases measurable by RECIST 1.1, including at least one lung metastasis amenable for SBRT, defined as following:
  • Tumor size between 1cm and 3 cm, AND
  • Peripheral tumor located further than 2 cm of the proximal bronchial tree (carina, right and left main bronchi, and bronchial tree to the second bifurcation)
  • Metastatic disease pretreated by at least one anthracycline based chemotherapy, but no more than 3 lines of standard therapy
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  • Age ≥ 18 years at time of study entry
  • ECOG performance status of 0 or 1
  • Body Weight > 35 kg
  • Life expectancy of at least 3 months
  • Previous treatment ended at least 4 weeks prior to first dose
  • Adequate Hematology laboratory data within 28 days prior to start of treatment: Absolute neutrophils ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hemoglobin ≥ 9 g/dL
  • Adequate Biochemistry laboratory data within 28 days prior to start of treatment: Total bilirubin ≤ 1.5 x ULN (except patient with confirmed Gilbert's syndrome or liver metastasis: Total bilirubin ≤ 3 X ULN), Transaminases ≤ 3 x ULN, Alkalin phosphatases ≤ 5 x ULN, Creatinine clearance ≥ 45 mL/min (Cockcroft)
  • Adequate cardiac function defined as follow: LVEF (as assessed by echocardiography or multiple-gated acquisition scan) ≥ 50% / Troponin I or T ≤ ULN (per institutional guidelines and/or not clinically significant per investigator judgement) / QTcF ≤ 480msec
  • Women should be post-menopaused or willing to accept the use of at least one highly effective method of birth control from screening to 90 days after the last dose of MEDI5752. All non-menopaused women should have a negative pregnancy test within 72 hours prior to study dosing. Men should accept to use an effective contraception from screening to 90 days after the last dose of MEDI5752
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
  • Signed written informed consent before any study procedure
  • Patient affiliated to a Social Health Insurance in France

Who cannot join

  • Patients with no lung metastases amenable for SBRT
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to use effective birth control from screening to 90 days after the last dose of MEDI5752
  • Any malignancy other than the disease under study in the past 2 years excepting curatively treated skin cancers such as Basal Cell Carcinoma or Squamous Cell Carcinoma.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed.
  • Uncontrolled hypercalcemia (> 1.5 mmol/L ionized calcium or Ca > 12 mg/dL or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab.
  • Severe, active co-morbidity, defined as follows:
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  • Unstable angina, uncontrolled cardiac arrhythmia, uncontrolled hypertension, symptomatic congestive heart failure
  • Transmural myocardial infarction within the last 6 months prior to registration
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Uncontrolled Chronic Obstructive Pulmonary Disease or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic disease
  • Known HIV positive status (positive for HIV-1 or HIV-2 antibodies)
  • End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
  • Active or uncontrolled hepatitis B (HBV) or hepatitis C (HCV). Participants are eligible if they:
  • Have controlled hepatitis C viral load defined as undetectable hepatitis C RNA by PCR either spontaneously or response to a successful prior course of anti-hepatitis C therapy
  • Have received HBV vaccination with only anti-HBS positivity and no clinical signs of hepatitis
  • Are HBsAg- and anti-HBc+ (ie, those who have cleared HBV after infection) and meet conditions i-iii below:
  • Are HBsAg+ with chronic HBV infection (lasting 6 months or longer) and meet conditions i-iii below:
  • HBV DNA viral load <100 IU/mL ii. Have normal transaminases values, or, if liver metastases are present, abnormal transaminases, with a result of AST/ALT <3xULN, which are not attributable to HBV infection iii. Start or maintain antiviral treatment if clinically indicated as per the investigator
  • Active hepatitis A
  • Active infection including tuberculosis (TB) (clinical evaluation that includes clinical history, physical examination, and radiographic findings and TB testing in line with local practice)
  • Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease (eg, colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, pneumonitis (past medical history of ILD, drug-induced ILD, or radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD), etc. The following are exceptions to this criterion:
  • Subjects with vitiligo or alopecia
  • Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Subjects with celiac disease controlled by diet alone.
  • History of organ transplant.
  • History of a reaction to any human gamma globulin therapy.
  • Known allergy or hypersensitivity to investigational product, or any excipients of the investigational product
  • Patients with leptomeningeal carcinomatosis
  • Patients with intra cranial metastasis may be eligible if all known lesions have been treated (with stereotactic radiotherapy or surgery or both AND there has been no evidence of disease progression in the CNS for ≥ 4 weeks after treatment and within 28 days prior the first dose of study drug administration
  • Previously Irradiation by SBRT should respect following maximal doses to at-risk structures:
  • Spinal cord irradiated to > 40 Gy
  • Brachial plexus irradiated to > 50 Gy
  • Lung previously with prior V20Gy > 30%
  • Any approved anticancer therapy, including chemotherapy, hormonal therapy or radiotherapy, within 4 weeks prior to initiation of study treatment and while on study treatment; however, the following are allowed: Hormone-replacement therapy or oral contraceptives. Palliative radiotherapy for bone metastases > 2 weeks prior to Cycle 1, Day 1.
  • Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI CTCAE v5.0 Grade ≤ 1 or baseline
  • Major surgery within 4 weeks prior to the first dose of investigational product or still recovering from prior surgery. Note: Local surgery of isolated lesions for palliative intent is acceptable
  • Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1. NOTE: Subjects, if enrolled, should not receive live vaccine while receiving investigational product and up to 30 days after the last dose of investigational product
  • Current or prior use of treatment with systemic corticosteroids or other systemic immunosuppressive or immunomodulating medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor [TNF] agents) within 14days prior to the first dose of investigational product. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroids injections (eg. Intraarticular injection)
  • Steroids as premedication for hypersensitivity reactions (eg CT scan premedication; single palliative dose for pain control etc.)
  • Patient already enrolled in another therapeutic trial involving an investigational substance, and when such a substance has been taken during the previous 4 weeks. The current enrollment in an observational (non interventional) clinical study or the follow-up period of an interventional study is permitted.
  • Prior treatment with PDL-1, PD-1 or CTLA4 blocking agents
  • Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • Institut Bergonié

    Bordeaux

  • Centre Oscar Lambret

    Lille

  • Centre Leon Berard

    Lyon

  • Institut Regional Du Cancer de Montpellier

    Montpellier

  • IUCT-O

    Toulouse

Other trials in France

About this study

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

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:

Read more

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.

Being tested
SBRT + MEDI5752
Keywords
Soft Tissue Sarcoma, Lung metastasis, Bispecific antibody anti PD-1/CTLA-4, Stereotactic body hypo-fractionated radiotherapy
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBRT + MEDI5752Combination product

    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
Study groups in NCT05821231
Study groupRoleWhat they receive
Patients with metastatic soft tissue sarcoma with lung metastasesExperimentalNot described
Receives: Combination Product: SBRT + MEDI5752

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose exploration Phase: The incidence of the Dose-limiting toxicity (DLT)

    For each patient, DLT incidence will be evaluated during the first cycle.

    Measured: 6 weeks after the last dose of radiotherapy for each patient

  2. Expansion phase: the rate of patients alive and without progression at 3 months.

    Measured: 3 months post treatment for each patient

Secondary outcomes (6)

  1. Dose exploration and Expansion Phases: The incidence of Treatment-Emergent Adverse Events will be evaluated using the NCI-CTCAE Version 5.0.

    Measured: 15 months for each patient

  2. 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).

    Measured: 15 months for each patient

  3. 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.

    Measured: 15 months for each patient

  4. 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.

    Measured: 15 months for each patient

  5. 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.

    Measured: 15 months for each patient

  6. Dose exploration and Expansion Phases: Overall Survival (OS) defined as the time from treatment initiation to death from any cause.

    Measured: 15 months for each patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start12 Dec 2023
  3. Primary completion7 Sep 2026
  4. Study completion7 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05821231
Sponsor's protocol ID
21SARC04
Acronym
MEDISARC-SBRT
Status last verified
Sep 2026
First submitted
7 Apr 2023
Last updated
11 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SBRT + MEDI5752 in people with Soft Tissue Sarcoma, run by Institut Claudius Regaud at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose exploration Phase: The incidence of the Dose-limiting toxicity (DLT) (time frame: 6 weeks after the last dose of radiotherapy for each patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05821231.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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