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A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients

ConditionHigh-Risk Neuroblastoma
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-18
SponsorRenaissance Pharma Ltd.

About this trial

Neuroblastoma is the most common type of solid cancer found outside the brain in young children. Generally, it affects children younger than 5 years old, with the average age when it is found being just 2 years. Most patients have 'high-risk' disease, with spread of the disease to different sites (metastases). This multinational study aims to find out how effective and safe the treatment of a monoclonal anti-GD2 antibody hu14.18K322A (daretabart) is when used together with chemotherapy to treat children and young people who have high-risk neuroblastoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Are ≥18 months to <18 years of age at time of informed consent or assent.

Are initially diagnosed with histologically proven HRNB with metastatic disease.

Have evaluable or measurable disease per International Neuroblastoma Response Criteria (INRC)

Have a Lansky performance status of ≥50 (≤16 years ) or Karnofsky performance status ≥50% (for >16 years).

Disqualifiers

Any active uncontrolled infection at the time of enrollment. Any known history of infection with human immunodeficiency virus (HIV), or active or chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).

Any contraindications to any of the study treatments.

Patients with >Grade 2 diarrhea.

Patients with disease of any major organ system that would compromise their ability to withstand chemoimmunotherapy.

Trial design

Design model

Single group

Treatments tested in this trial

  • hu1418K322A + Temozolomide + Irinotecan

    Drug

    21-day cycle for a maximum of 12 cycles

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Higher doseOther 1 intervention
Group B: Lower doseOther 1 intervention

Trial outcomes

Primary outcomes

1

Overall response rate (ORR)

Proportion of participants treated with hu14.18K322A in combination with chemotherapy who achieve a complete response (CR) or partial response (PR) according to the International Neuroblastoma Response Criteria (INRC)

Time frame
Assessed at end of treatment (up to 12 months)
2

Metastatic complete response rate (mCRR)

Proportion of participants treated with hu14.18K322A in combination with chemotherapy who achieve an overall metastatic complete response (mCR) response

Time frame
Assessed at end of treatment (up to 12 months)

Secondary outcomes

1

Overall survival (OS)

Time frame
Up to 3 years
2

Overall Metastatic Response Rate (mORR)

Time frame
Assessed at end of treatment (up to 12 months)
3

Duration of Response (DOR)

Time frame
From the time of first response until disease progression, discontinuation from study, start of new therapy, or death
4

Progression-Free Survival (PFS)

Time frame
From start of Cycle 1 until the first occurrence of progression followed for up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Renaissance Pharma Ltd.

Lead sponsor

Source ClinicalTrials.gov
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