Doxorubicin With or Without DT-7012 in Advanced Soft Tissue Sarcoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGustave Roussy, Cancer Campus, Grand Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
DT-7012
DrugDT-7012 administered IV at 10 mg/kg on Day 1 of each 21-day cycle for a total maximum of 24 months
Doxorubicin
DrugDoxorubicin 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
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Standard Treatment ArmActive comparator 1 intervention
Group B: Doxorubicin + DT-7012 :Experimental treatment 2 interventions
Trial outcomes
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
Time frame
from the enrollment to 24 weeks after treatment onsetSponsors and contacts
Click on the lead sponsor to view all of their trials.
Gustave Roussy, Cancer Campus, Grand Paris
Lead sponsor
AGENCE NATIONALE DE RECHERCHE
Collaborator
Source ClinicalTrials.gov
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