International Phase I Trial of Dinutuximab Beta With VDC/IE in GD2-Positive Ewing Sarkoma (NCT06839703) | Clinical Trial Compass
Not Yet RecruitingPhase 1
International Phase I Trial of Dinutuximab Beta With VDC/IE in GD2-Positive Ewing Sarkoma
18 participantsStarted 2025-03-01
Plain-language summary
The goal of the study is to investigate the feasibility, toxicity, and biological activity of the treatment with dinutuximab beta in combination with standard chemotherapy in EWS to give high-risk patients with a GD2 positiv pumor a benefit in treatment. Within the study is tested with three different dosages in a 3+3 design with three pre-defined dose levels.
Who can participate
Age range12 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically confirmed, newly diagnosed Ewing Sarcoma (m/f/d) or so-called Ewing-like sarcoma (i.e. translocation-positive small blue round cell sarcoma other than Rhabdomyosarcoma) of bone and / or soft tissue with evidence of EWS translocation by fluorescence in situ hybridization (FISH), real-time polymerase chain reaction (RT-PCR), or next-generation sequencing (NGS) assay
✓. High risk stratification (metastatic disease)
✓. Centrally confirmed GD2-positive tumor (biopsy of original and/or residual tumor or liquid biopsy in peripheral blood)
✓. Availability of fresh frozen tumor tissue for central GD2-detection
✓. Age ≥12 months
✓. Start of first line treatment according to standard induction treatment (Cycle 1-4: VDC - IE - VDC - IE)
✓. Wash-out phase with a minimum of 14 days after the last the dose of the last chemotherapy
✕. Patients with hypersensitivity against at least 1 component of the investigational medicinal product
✕. Significant illnesses and/or any of the following:
✕. Active and uncontrolled CNS metastases (indicated by clinical symptoms, cerebral edema, corticosteroid and/or anticonvulsant requirement, or progressive disease); for controlled CNS metastases, patient should have been off corticosteroids for at least 28 days without overt evidence of significant neurological deficits prior to enrollment
What they're measuring
1
GD2 Positivity
Timeframe: after initial diagnosis and before study enrolment
✕. Significant cardiac conduction abnormalities, including known familial prolonged QT syndrome, or screening QTc \>480 msec
✕. Active, uncontrolled infection or an unexplained fever \>38.5°C which in the Investigator's opinion might compromise the patient's participation in the study or affect the study outcome
✕. Chronic Grade ≥2 diarrhea
✕. Diagnosis of any malignancy other than the disease under study