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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07802652 on ClinicalTrials.gov