Doxorubicin With or Without DT-7012 in Advanced Soft Tissue Sarcoma

NCT07802652 | Not Yet Recruiting Phase 2

• 2 other identifiers: 2026-527800-26-00CSET number 2026/4424
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Undifferentiated Pleomorphic Sarcoma (UPS); Dedifferentiated Liposarcoma (DDLPS)

Outcome Measures

Primary Outcomes (1)

• 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

  from the enrollment to 24 weeks after treatment onset

Study Arms (2)

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

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

Drug: DT-7012; Drug: Doxorubicin

Interventions

DT-7012 DRUG

DT-7012 administered IV at 10 mg/kg on Day 1 of each 21-day cycle for a total maximum of 24 months

Doxorubicin + DT-7012 :

Doxorubicin DRUG

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

Doxorubicin + DT-7012 :; Standard Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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. \[8-10\]
• 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.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead
• AGENCE NATIONALE DE RECHERCHE: collaborator

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94800, France

Location

MeSH Terms

Conditions

Histiocytoma, Malignant Fibrous; Liposarcoma

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Histiocytoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms, Adipose Tissue

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Antoine ITALIANO, MD, PhD

CONTACT

(+33)1 42 11 42 11 line 34 71; antoine.italiano@gustaveroussy.fr

Timothé DENAËS, PhD

CONTACT

(+33)1 42 11 42 11 line 55 54; timothe.denaes@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): November 1, 2031
• Last Updated: September 15, 2026

Record last verified: 2026-08

Locations

FR (1)