Qarziba 4.5 mg/mL concentrate for solution for infusion

DRUG5 trials

Sponsors

Prinses Maxima Centrum voor Kinderoncologie B.V., Uniwersytet Jagiellonski Collegium Medicum, Institut Gustave Roussy, The University Of Birmingham, IRCCS Istituto Giannina Gaslini

Conditions

High risk relapsed neuroblastoma (relapsed or progressed after being defined as High Risk at any time following diagnosis or progressed/relapsed as high-risk neuroblastoma)NeuroblastomaPatient affected by high risk Neuroblastoma relapsed or in progression after first line treatment.Patients with High Risk NeuroblastomaRecurrent or progression of neuroblastoma or neuroblastoma or neuroblastoma refractory to first-line treatment.which is histologically proven as per International Neuroblastoma Staging System (INSS) definition.

Phase 1

Phase Ib study combining dinutuximab beta with induction chemotherapy regimens in patients with newly diagnosed high-risk neuroblastoma: SIOPEN-Pilot01

RecruitingCTIS2023-509673-22-00

Prinses Maxima Centrum voor Kinderoncologie B.V.Neuroblastoma

Start: 2024-12-02Target: 39Updated: 2025-09-11

BEACON 2: A Multi-Arm, Multi-Stage Platform Trial For Relapsed Neuroblastoma

Not yet recruitingCTIS2024-516115-24-00

The University Of BirminghamHigh risk relapsed neuroblastoma (relapsed or progressed after being defined as High Risk at any time following diagnosis or progressed/relapsed as high-risk neuroblastoma), which is histologically proven as per International Neuroblastoma Staging System (INSS) definition.

Target: 102Updated: 2025-12-15

Phase 2

TCRaß+CD19+ depleted haploidentical stem cell transplantation followed by immunotherapy in patients with relapsed/resistant high-risk neuroblastoma

RecruitingCTIS2024-519089-32-02

IRCCS Istituto Giannina GasliniPatient affected by high risk Neuroblastoma relapsed or in progression after first line treatment.

Start: 2023-08-29Target: 19Updated: 2025-01-31

Phase 3

Immunotherapy with dinutuximab beta in combination with chemotherapy for the treatment of patients with primary neuroblastoma refractory to standard therapy and with relapsed or progressive disease.

Not yet recruitingCTIS2024-513141-37-00

Uniwersytet Jagiellonski Collegium MedicumRecurrent or progression of neuroblastoma or neuroblastoma or neuroblastoma refractory to first-line treatment.

Target: 28Updated: 2024-05-06

High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) “Randomized, international and multicentric phase 3 study that evaluates and compares 2 treatment strategies in 3 therapeutic phases (induction, high-dose chemotherapy and radiotherapy) for patients with high-risk neuroblastoma and introduces chemoimmunotherapy for patients with insufficient metastatic response after induction chemotherapy

RecruitingCTIS2024-514917-36-00

Institut Gustave RoussyPatients with High Risk Neuroblastoma

Start: 2024-11-21Target: 719Updated: 2025-01-17