Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta as Maintenance Therapy in Chinese Patients With High-risk Neuroblastoma

• Sponsor: BeiGene (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05373901
• Collaborator: (none)
• Enrollment: 8
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 18.8
• Patients Per Site: 2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is an open-label, multi-center, single-arm, Phase 1 study. The purpose of this study is for evaluating the safety and pharmacokinetics of dinutuximab beta as maintenance therapy in Chinese patients with high-risk neuroblastoma

Condition or Disease	Intervention/Treatment	Phase
High-risk Neuroblastoma	Drug: Dinutuximab Beta; Drug: 13 cis retinoic acid	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Multi-Center, Single-Arm, Phase 1 Study Evaluating the Safety and Pharmacokinetics of Dinutuximab Beta as Maintenance Therapy in Chinese Patients With High-Risk Neuroblastoma
• Actual Study Start Date: Jun 7, 2022
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dinutuximab beta cohort Patients who received dinutuximab beta as maintenance therapy	Drug: Dinutuximab Beta; Administered via intravenous infusion; Drug: 13 cis retinoic acid; Administered orally

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events (AEs) [Up to 2 years]

   Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

2. Area under the serum-concentration-time curve (AUC) of dinutuximab beta [approximately 20 weeks]

3. Maximum observed serum concentration (Cmax) of dinutuximab beta [approximately 20 weeks]

4. Minimum observed serum concentration (Cmin) of dinutuximab beta [approximately 20 weeks]

5. Time to reach maximum observed serum concentration (Tmax) of dinutuximab beta [approximately20 weeks]

6. Apparent terminal elimination half life (t1/2) of dinutuximab beta [approximately 20 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

1. Signed informed consent form (ICF) and ability to comply with study requirements

2. Age ≥ 12 months at consent

3. Diagnosis of high-risk neuroblastoma according to the International Neuroblastoma Staging System (INSS) criteria.

4. Patients who have previously received induction chemotherapy and achieved a partial or complete response followed by myeloablative therapy and stem cell transplantation. Stem cell transplantation should be completed within 120 days of dinutuximab beta first administration

Exclusion Criteria:

1. Hypersensitivity to ≥ 1 component of dinutuximab beta antibody or against mouse proteins

2. Actively progressive disease (not stabilized) or recurrent disease at the time of inclusion into the study

3. Previous treatment with anti-GD2 antibody before enrolling in this study

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Children's Hospital, Capital Medical University	Beijing	Beijing	China
2	Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine	Shanghai	Shanghai	China
3	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin	China
4	The Children's Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang	China

Sponsors and Collaborators

• BeiGene

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BeiGene
• ClinicalTrials.gov Identifier: NCT05373901
• Other Study ID Numbers: BGB-dinutuximab beta-101
• First Posted: May 13, 2022
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neuroblastoma; Tretinoin; Dinutuximab; Isotretinoin

Study Results

No Results Posted as of Jun 21, 2022