A Randomized Phase II Study of Doxorubicin With or Without DT-7012 in Advanced Soft Tissue Sarcoma
NCT07802652 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-09-03
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)
Interventions
- DRUG
-
DT-7012
DT-7012 administered IV at 10 mg/kg on Day 1 of each 21-day cycle for a total maximum of 24 months
- 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
Sponsors & Collaborators
-
AGENCE NATIONALE DE RECHERCHE
collaborator UNKNOWN -
Gustave Roussy, Cancer Campus, Grand Paris
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2027-02-01
- Primary Completion
- 2031-11-01
- Completion
- 2031-11-01
Countries
- France
Study Locations
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