Undifferentiated Pleomorphic Sarcoma (UPS)Phase 2IMMUSARC-7012NCT07802652
Doxorubicin With or Without DT-7012 in Advanced Soft Tissue Sarcoma
A Phase 2 study testing DT-7012 and Doxorubicin in people with Undifferentiated Pleomorphic Sarcoma (UPS) and Dedifferentiated Liposarcoma (DDLPS), run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
The primary objective of this randomized phase II trial is to assess, independently in advanced/metastatic UPS and DDLPS, the antitumor activity of DT-7012 combined with doxorubicin as first-line systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Undifferentiated Pleomorphic Sarcoma (UPS), Dedifferentiated Liposarcoma (DDLPS)
- What is being tested?
- DT-7012 and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2027to 1 Nov 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years at the time of signature of the informed consent form.
- Written informed consent obtained before any study-specific procedure. The participant must be able to understand the study requirements and must be willing and able to comply with scheduled visits, treatment, laboratory tests, imaging assessments, translational sample collection, and other protocol procedures.
- Histologically confirmed diagnosis of one of the following soft-tissue sarcoma subtypes: undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS). Pathology review and/or confirmation by the French sarcoma reference pathology network (RRePS) or an equivalent expert sarcoma pathology review process is required whenever applicable according to national practice. [1,2]
- Locally advanced/unresectable and/or metastatic disease not amenable to curative-intent surgery or curative-intent radiotherapy, as assessed by the Investigator in the context of multidisciplinary sarcoma management.
- Assignment to the appropriate histology-specific cohort before randomization: UPS participants will be enrolled in Cohort A, and DDLPS participants will be enrolled in Cohort B.
- Prior neoadjuvant and/or adjuvant systemic therapy is allowed if completed at least 6 months before randomization, provided that prior anthracycline exposure does not preclude safe administration of protocol doxorubicin according to institutional standards and cumulative lifetime anthracycline limits.
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- At least one measurable lesion according to RECIST v1.1. A measurable lesion must be accurately measurable in at least one dimension and have a longest diameter of ≥ 10 mm by CT scan or MRI, except for lymph nodes, which must have a short-axis diameter of ≥ 15 mm. Lesions located in a previously irradiated field may be considered measurable only if unequivocal progression has been documented after completion of radiotherapy. [21]
- Baseline tumor assessment performed by CT scan and/or MRI according to RECIST v1.1 within the protocol-defined screening window before randomization. [21]
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Life expectancy > 3 months according to the Investigator.
- Eligible to receive doxorubicin-based first-line chemotherapy, including adequate cardiac function with left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography or multigated acquisition scan (MUGA) performed during screening or within a period acceptable according to institutional practice, provided no intervening cardiac event has occurred.
- Adequate hematologic and end-organ function, based on laboratory values obtained within 7 days prior to randomization unless otherwise specified.
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL. Transfusion and/or growth factor support immediately before screening laboratory evaluation should be documented and should not be used to mask persistent inadequate bone marrow function.
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN), except for participants with Gilbert syndrome, for whom total bilirubin ≤ 3 x ULN is acceptable provided direct bilirubin is within normal range or clinically acceptable.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN in the presence of liver metastases.
- Alkaline phosphatase ≤ 2.5 x ULN, or ≤ 5 x ULN in the presence of liver and/or bone involvement attributable to disease.
- Serum albumin ≥ 30 g/L.
- Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 30 mL/min according to Cockcroft-Gault or local institutional standard method.
- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN, unless the participant is receiving anticoagulant therapy and coagulation parameters are within the expected therapeutic range for that treatment.
- Adequate washout from prior anticancer therapy, if applicable: at least 5 half-lives or 28 days (whichever is longer) since the last dose of prior systemic chemotherapy or immunotherapy, and at least 2 weeks since the last radiotherapy or other local anticancer therapy, unless a shorter interval is clinically justified and approved by the Sponsor or Coordinating Investigator. Palliative radiotherapy to non-target lesions may be allowed if completed before randomization and if all acute toxicity has resolved to Grade ≤ 1.
- Recovery to Grade ≤ 1 from prior treatment-related toxicities according to NCI CTCAE v 6.0, except alopecia of any grade, vitiligo of any grade, endocrinopathies controlled by replacement therapy, or non-painful peripheral neuropathy Grade ≤ 2. [24]
- Patients shall be eligible to undergo IMP treatment and tumor biopsies. Patients who either do not consent to a tumor biopsy or do not have accessible lesions will not be eligible.
- Availability of representative archival tumor material when feasible and willingness to allow its use for protocol-defined translational research. A fresh pretreatment biopsy is strongly recommended when clinically feasible and safe; refusal or inability to undergo a fresh biopsy should not preclude enrollment unless otherwise specified in the translational laboratory manual.
- Willingness to provide protocol-defined blood samples for translational and pharmacodynamic research, including baseline and on-treatment samples, as specified in the schedule of assessments.
- For women of childbearing potential *: negative serum or certified highly sensittive urine pregnancy test within 72 hours before the first dose of study treatment (In the event of a positive or uninterpretable urine result, a confirmatory serum pregnancy test must be performed immediately) and willingness to use highly effective contraception** during study treatment and after the last dose of study treatment for the period required by doxorubicin and DT-7012 risk management, i.e. at least 6 months after the last dose of doxorubicin and/or at least 6 months after the last dose of DT-7012, whichever is longer. [8-10]
- For male participants with a partner of childbearing potential: willingness to use effective contraception during study treatment and for at least 6 months after the last dose of doxorubicin and/or at least 6 months after the last dose of DT-7012, whichever is longer. Male participants should refrain from sperm donation during this period. [8-10] . In addition, the female partner of childbearing potential should use highly effective method of contraception during trial participation starting with the Informed Consent Form signature and for at least 6 months after the last dose of DT-7012
- Affiliation to a social security system, or beneficiary of such a system, in compliance with French law relating to biomedical research.
Who cannot join
- Diagnosis of a sarcoma subtype other than UPS or DDLPS, including well-differentiated liposarcoma without a dedifferentiated component, gastrointestinal stromal tumor, Kaposi sarcoma, desmoid tumor, Ewing sarcoma, rhabdomyosarcoma, bone sarcoma, or any other non-eligible histology. [2]
- Disease considered amenable to curative-intent local therapy at the time of screening.
- Prior systemic anticancer therapy for locally advanced/unresectable or metastatic disease.
- Prior exposure to DT-7012 or any other CCR8-targeting agent.
- Prior exposure to anthracyclines at or above the maximum cumulative dose allowed (550 mg/m²) according to the doxorubicin summary of product characteristics, institutional standards, or Investigator assessment, or any prior anthracycline-related cardiomyopathy. Participants for whom prior anthracycline exposure would prevent safe protocol doxorubicin administration are not eligible.
- Known hypersensitivity or contraindication to doxorubicin, DT-7012, any of their excipients, or compounds of similar chemical or biological composition, including history of severe allergic, anaphylactic, or other hypersensitivity reactions to monoclonal antibodies or fusion proteins. [8-10]
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- Any contraindication to doxorubicin according to applicable product information, including but not limited to severe myocardial insufficiency, recent myocardial infarction, severe arrhythmia, severe persistent myelosuppression, severe hepatic impairment, or uncontrolled infection.
- Active or uncontrolled autoimmune disease or immune deficiency requiring systemic treatment. Exceptions may include stable autoimmune-related hypothyroidism on hormone replacement, type 1 diabetes mellitus on insulin, stable adrenal or pituitary insufficiency on replacement therapy, vitiligo, psoriasis, or eczema not requiring systemic immunosuppressive therapy, after Investigator assessment.
- Treatment with systemic immunosuppressive medication within 14 days prior to Cycle 1 Day 1, or anticipated need for systemic immunosuppressive medication during study treatment, with the exception of physiologic replacement corticosteroids, inhaled or topical corticosteroids, local steroid injections, premedication for hypersensitivity prophylaxis, or short-course steroids used for management of adverse events according to protocol.
- Chronic systemic corticosteroid therapy at a dose > 10 mg/day prednisone equivalent within 14 days prior to Cycle 1 Day 1, unless approved by the Sponsor or Coordinating Investigator for a non-immunosuppressive indication.
- Any prior Grade ≥ 3 immune-related adverse event related to previous immunotherapy, or any unresolved immune-related adverse event > Grade 1, except endocrinopathy controlled by replacement therapy.
- Administration of a live attenuated vaccine within 30 days prior to the first dose of study treatment, or planned administration of a live attenuated vaccine during study treatment. Inactivated vaccines and non-live vaccines are permitted according to local recommendations.
- Active infection requiring systemic therapy within 2 weeks prior to Cycle 1 Day 1, severe infection within 4 weeks prior to Cycle 1 Day 1, active tuberculosis, or any uncontrolled intercurrent infection. [29]
- Known active hepatitis B infection, active hepatitis C infection, or uncontrolled HIV infection. Participants with resolved hepatitis B infection or controlled chronic viral infection may be eligible according to local standards and after appropriate specialist assessment, provided antiviral prophylaxis/monitoring is implemented when indicated.
- Symptomatic, untreated, or unstable central nervous system metastases or leptomeningeal disease. Participants with previously treated CNS lesions may be eligible if clinically stable, off prohibited corticosteroids, and without evidence of progression according to Investigator assessment.
- History of idiopathic pulmonary fibrosis, non-infectious pneumonitis requiring systemic corticosteroids, organizing pneumonia, drug-induced pneumonitis, immune-related pneumonitis, current interstitial lung disease, or evidence of active pneumonitis on screening imaging. Radiation-induced fibrosis confined to a prior radiation field is permitted if clinically stable.
- Uncontrolled or clinically significant cardiovascular disease, including but not limited to myocardial infarction, acute coronary syndrome, coronary angioplasty/stenting or bypass grafting within 6 months; stroke or transient ischemic attack within 6 months; uncontrolled angina within 3 months; clinically significant arrhythmia; QTc > 480 ms; congestive heart failure NYHA class III or IV; cardiomyopathy; clinically significant pericardial effusion; or poorly controlled venous thromboembolic disease.
- Uncontrolled hypertension, defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 110 mmHg despite appropriate medical management. Participants with initial blood pressure elevation may be eligible if blood pressure is controlled before randomization.
- Major surgery within 4 weeks prior to randomization or failure to recover adequately from surgery. Participants must have adequate wound healing before initiation of study treatment.
- Pregnant or breastfeeding women, or participants intending to become pregnant or father a child during the study or within the protocol-defined post-treatment contraception period.
- Prior or concurrent malignancy within the past 2 years, except malignancies with negligible risk of metastasis or death and treated with expected curative outcome, including adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ treated with curative intent, superficial/non-invasive bladder cancer, or endoscopically resected gastrointestinal neoplasia limited to the mucosa with no recurrence for more than 1 year.
- Participation in another interventional clinical trial with an investigational medicinal product within 30 days before randomization or within 5 half-lives of the investigational product, whichever is longer. Participation in non-interventional studies or registries is permitted provided that it does not interfere with this protocol.
- Known alcohol or drug abuse, psychiatric disorder, social situation, geographic constraint, or any other condition that, in the Investigator's opinion, may compromise participant safety, interfere with study treatment administration, impair compliance with study procedures, or affect interpretation of study results.
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
- Any other condition that, in the Investigator's opinion, makes participation in the clinical trial undesirable or unsafe.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Gustave Roussy
Villejuif, Val de Marne, 94800
Antoine ITALIANO, MD, PhD, (+33)1 42 11 42 11 line 34 71, antoine.italiano@gustaveroussy.fr
About this study
Official title: A Randomized Phase II Study of Doxorubicin With or Without DT-7012 in Advanced Soft Tissue Sarcoma
The primary objective of this randomized phase II trial is to assess, independently in advanced/metastatic UPS and DDLPS, the antitumor activity of DT-7012 combined with doxorubicin as first-line systemic therapy.
- Being tested
- DT-7012, Doxorubicin
- Medical subject headings
- Histiocytoma, Malignant Fibrous, Liposarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT-7012Drug
DT-7012 administered IV at 10 mg/kg on Day 1 of each 21-day cycle for a total maximum of 24 months
DoxorubicinDrug
Doxorubicin administered IV at 75 mg/m2 on Day 1 of each 21-day cycle, up to 6 cycles or according to cumulative dose limits and local standards
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment Arm | Active comparator | Doxorubicin alone at 75 mg/m2 on Day 1 of each 21-day cycle, up to 6 cycles or according to cumulative dose limits and local standards Receives: Drug: Doxorubicin |
| Doxorubicin + DT-7012 : | Experimental | Doxorubicin at 75 mg/m2 on Day 1 of each 21-day cycle, up to 6 cycles or according to cumulative dose limits and local standards associated with DT-7012 at 10 mg/kg on Day 1 of each 21-day cycle up to 24 months maximum Receives: Drug: DT-7012; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month progression-free rate (PFR6)
6-month progression-free rate (PFR6), defined as the proportion of participants alive and progression-free 24 weeks after treatment onset, with complete response, partial response, or stable disease according to RECIST v1.1
Measured: from the enrollment to 24 weeks after treatment onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Nov 2031 (estimated)
- Study completion1 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undifferentiated Pleomorphic Sarcoma (UPS)Studies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- AGENCE NATIONALE DE RECHERCHE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802652
- Sponsor's protocol ID
- 2026-527800-26-00
- Other IDs
- CSET number 2026/4424
- Acronym
- IMMUSARC-7012
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Doxorubicin With or Without DT-7012 in Advanced Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT07802652
- Acronym / sponsor ID
- IMMUSARC-7012 / 2026-527800-26-00
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- AGENCE NATIONALE DE RECHERCHE
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Nov 2031 (estimated)
- Study completion
- 1 Nov 2031 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this randomized phase II trial is to assess, independently in advanced/metastatic UPS and DDLPS, the antitumor activity of DT-7012 combined with doxorubicin as first-line systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment Arm | Active comparator | Drug: DoxorubicinDoxorubicin alone at 75 mg/m2 on Day 1 of each 21-day cycle, up to 6 cycles or according to cumulative dose limits and local standards |
| Doxorubicin + DT-7012 : | Experimental | Drug: DT-7012, Drug: DoxorubicinDoxorubicin at 75 mg/m2 on Day 1 of each 21-day cycle, up to 6 cycles or according to cumulative dose limits and local standards associated with DT-7012 at 10 mg/kg on Day 1 of each 21-day cycle up to 24 months maximum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Age ≥ 18 years at the time of signature of the informed consent form.
- Written informed consent obtained before any study-specific procedure. The participant must be able to understand the study requirements and must be willing and able to comply with scheduled visits, treatment, laboratory tests, imaging assessments, translational sample collection, and other protocol procedures.
- Histologically confirmed diagnosis of one of the following soft-tissue sarcoma subtypes: undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS). Pathology review and/or confirmation by the French sarcoma reference pathology network (RRePS) or an equivalent expert sarcoma pathology review process is required whenever applicable according to national practice. [1,2]
- Locally advanced/unresectable and/or metastatic disease not amenable to curative-intent surgery or curative-intent radiotherapy, as assessed by the Investigator in the context of multidisciplinary sarcoma management.
- Assignment to the appropriate histology-specific cohort before randomization: UPS participants will be enrolled in Cohort A, and DDLPS participants will be enrolled in Cohort B.
Key exclusion criteria (25 listed)
- Diagnosis of a sarcoma subtype other than UPS or DDLPS, including well-differentiated liposarcoma without a dedifferentiated component, gastrointestinal stromal tumor, Kaposi sarcoma, desmoid tumor, Ewing sarcoma, rhabdomyosarcoma, bone sarcoma, or any other non-eligible histology. [2]
- Disease considered amenable to curative-intent local therapy at the time of screening.
- Prior systemic anticancer therapy for locally advanced/unresectable or metastatic disease.
- Prior exposure to DT-7012 or any other CCR8-targeting agent.
- Prior exposure to anthracyclines at or above the maximum cumulative dose allowed (550 mg/m²) according to the doxorubicin summary of product characteristics, institutional standards, or Investigator assessment, or any prior anthracycline-related cardiomyopathy. Participants for whom prior anthracycline exposure would prevent safe protocol doxorubicin administration are not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DT-7012DT-7012 administered IV at 10 mg/kg on Day 1 of each 21-day cycle for a total maximum of 24 months | Drug | Doxorubicin + DT-7012 : |
| DoxorubicinDoxorubicin administered IV at 75 mg/m2 on Day 1 of each 21-day cycle, up to 6 cycles or according to cumulative dose limits and local standards | Drug | Doxorubicin + DT-7012 :, Standard Treatment Arm |
Primary outcome
6-month progression-free rate (PFR6)
Time frame: from the enrollment to 24 weeks after treatment onset
6-month progression-free rate (PFR6), defined as the proportion of participants alive and progression-free 24 weeks after treatment onset, with complete response, partial response, or stable disease according to RECIST v1.1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DT-7012 and Doxorubicin in people with Undifferentiated Pleomorphic Sarcoma (UPS) and Dedifferentiated Liposarcoma (DDLPS), run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site 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 27 inclusion and 25 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: opening soon, as of the sponsor's last update on 15 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 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine ITALIANO, MD, PhD ((+33)1 42 11 42 11 line 34 71, antoine.italiano@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month progression-free rate (PFR6) (time frame: from the enrollment to 24 weeks after treatment onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2026.