Phase I/II trial of Dinutuximab beta in combination with Irinotecan and Rapamycin in pediatric, adolescents and adult patients with relapsed/refractory bone tumors. BONE DINIRRA

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-525463-40-00

Enrollment

Registered

2026-08-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteosarcomas, chondrosarcomas, Ewing sarcomas, Ewing-like tumors with rare fusions, CIC-DUX4 bone sarcomas

Brief summary

1° phase I: determination of the maximum tolerated dose (MTD) of Dinutuximab beta in combination with iv. Irinotecan and oral daily Sirolimus. Phase II : determination of the PFS rate in each histology group, at or before 16 weeks after the first dose of study drug, based on investigator assessment per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) version 1.1 and/or PET Response Criteria In Solid Tumor version 1.0 (PERCIST 1.0)

Interventions

DRUGQarziba 4.5 mg/mL concentrate for solution for infusion

DRUGSIROLIMUS

DRUGIRINOTECAN HYDROCHLORIDE TRIHYDRATE

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
1° phase I: determination of the maximum tolerated dose (MTD) of Dinutuximab beta in combination with iv. Irinotecan and oral daily Sirolimus. Phase II : determination of the PFS rate in each histology group, at or before 16 weeks after the first dose of study drug, based on investigator assessment per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) version 1.1 and/or PET Response Criteria In Solid Tumor version 1.0 (PERCIST 1.0)	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 21, 2026