Gudinutuximab Beta Added to Standard Chemo for GD2-Positive Ewing Sarcoma (Early-Phase Trial)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial is a Phase 1, 3+3 dose-escalation study evaluating dinutuximab beta in combination with the standard VDC/IE chemotherapy in GD2-expressing, high-risk Ewing sarcoma. Three predefined dose levels are tested to determine feasibility, tolerability, and preliminary biological activity. GD2 is used as a biomarker-driven target, with careful monitoring of safety and tumor response. Eligible participants are patients aged 12 months and older with newly diagnosed, metastatic or high-risk disease and confirmed GD2-positive tumors. The study is conducted at three German centers and led by a principal investigator from Universitätsmedizin Göttingen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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
2. High risk stratification (metastatic disease)
3. Centrally confirmed GD2-positive tumor (biopsy of original and/or residual tumor or liquid biopsy in peripheral blood)
4. Availability of fresh frozen tumor tissue for central GD2-detection
5. Age ≥12 months
6. Start of first line treatment according to standard induction treatment (Cycle 1-4: VDC - IE - VDC - IE)
7. Wash-out phase with a minimum of 14 days after the last the dose of the last chemotherapy
8. Lansky (\<16 years) Performance Score ≥70% or ECOG (≥16 years) ≤ 2
9. Adequate bone marrow function as evidenced by meeting all the following requirements:

   1. White blood cell count \> 2000/μl
   2. ANC ≥1000 cells/μL (G-CSF allowed)
   3. Platelet count 75,000 cells/μL without the use of platelet transfusion within the last 2 days
   4. Hemoglobin ≥9 g/dL without the use of red blood cell transfusion within the last 2 days
10. Adequate hepatic function as evidenced by meeting all the following requirements:

    1. Serum total bilirubin ≤1.5 x upper limit of normal (ULN)
    2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x ULN
11. Adequate cardiac function: confirmed by echocardiography with a left ventricular ejection fraction (LVEF) of ≥ 50%
12. Adequate renal function: creatinine clearance or glomerular filtration rate (GFR) \> 60 mL/min/1.73 m2
13. No known active HIV, HBV, or HCV infection
14. No severe neurological impairment, particularly no motor or sensory deficits, except for neurological deficits caused by Ewing sarcoma
15. Female patients of childbearing potential must present with a negative serum pregnancy test and agree to employ adequate birth control measures for the duration of the study and until 3 months after the end of treatment. Female patients who are lactating must agree to stop breast-feeding from the start of study treatment until 1 month after the end of treatment.
16. Patient or their legal representative is willing and able to comply with the requirements of the study protocol

Exclusion Criteria:

1. Relapsed or refractory Disease state
2. Patients with hypersensitivity against at least 1 component of the investigational medicinal product
3. Significant illnesses and/or any of the following:

   * significant psychiatric disabilities or uncontrolled seizure disorders
   * active uncontrolled peptic ulcer disease
   * clinically significant neurologic deficit or objective peripheral neuropathy
   * clinically significant, symptomatic fluid in a third space
4. 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
5. Significant cardiac conduction abnormalities, including known familial prolonged QT syndrome, or screening QTc \>480 msec
6. 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
7. Chronic Grade ≥2 diarrhea
8. Diagnosis of any malignancy other than the disease under study
9. Any other medical or social condition deemed by the Investigator to be likely to interfere with a patient's ability to cooperate and participate in the study or interfere with the interpretation of the results.

Where it's running

• Universitätsmedizin Göttingen
  Göttingen, Lower Saxony, Germany Recruiting
• Universitätsmedizin Essen
  Essen, North Rhine-Westfalia, Germany Recruiting
• Universitätsmedizin der Johannes Gutenberg-Universität
  Mainz, Rhineland-Palatinate, Germany Recruiting
• Universitätsmedizin Greifswald
  Greifswald, Mecklenburg-Vorpommern, Germany Not yet recruiting
• Helios Kliniken Berlin-Buch
  Berlin, State of Berlin, Germany Not yet recruiting

Study contacts

• Study coordinator: Helena Kerp, PhD
• Email: cess-gd2@gpoh-trials.org
• Phone: +49 201 74 94 96 0

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

  This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.

  Recruiting Phase 4 The First Hospital of Jilin University · Changchun, Jilin · NCT07908888

• Chemotherapy sensitivity-guided Culmerciclib combo for HR+/HER2- breast cancer before surgery

  This trial tests whether adding Culmerciclib to chemotherapy before surgery can help people with HR+/HER2- breast cancer who don’t respond to initial TAC treatment.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07900516

• Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL

  This trial tests whether adding orelabrutinib to the Pola-R-CHP regimen can improve outcomes for adults with intermediate- to high-risk newly diagnosed DLBCL.

  Recruiting at 2 sites The First Affiliated Hospital of Xiamen University · Xiamen, Fujian and 1 other locations · NCT07778212

• Pyrotinib plus trastuzumab and chemotherapy for HER2-positive early breast cancer

  This study tests a treatment combination of Pyrotinib, Trastuzumab and chemo given before surgery to see if it can improve responses in HER2-positive breast cancer patients who have not yet been treated.

  Recruiting Phase 2 Hebei Medical University Fourth Hospital · Shijiazhuang, Hebei · NCT07635342

• Polatuzumab vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in untreated DLBCL (MCD/BN2/N1)

  This study tests a targeted combination therapy to see if it can treat previously untreated DLBCL with specific molecular subtypes.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07608978

• Iberdomide added to chemoimmunotherapy for relapsed or refractory neuroblastoma

  This study tests whether adding iberdomide to a chemoimmunotherapy regimen helps children and young people with relapsed, refractory, or progressing neuroblastoma.

  Recruiting at 4 sites Phase 1/2 National Cancer Institute (NCI) · Oakland, California and 3 other locations · NCT07437963

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.