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NCT06047535
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response.
Phase 4 trial testing Naxitamab in Neuroblastoma in 62 participants. Not yet recruiting.
15 June 2027
Quick facts
| Lead sponsor | SciClone Pharmaceuticals |
|---|---|
| Phase | Phase 4 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 62 |
| Start date | 31 October 2023 |
| Primary completion | 15 June 2027 |
| Estimated completion | 15 August 2027 |
Drugs / interventions tested
- Naxitamab (NAXITAMAB) — full drug profile →
Conditions studied
- Neuroblastoma — all drugs for Neuroblastoma →
Sponsor
SciClone Pharmaceuticals — full company profile →
Who can join
12 Months and older, any sex, with Neuroblastoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-arm, multicenter clinical trial conducted in patients ≥ 12 months of age with high-risk neuroblastoma in first complete response. 62 patients will be enrolled to receive naxitamab + GM-CSF in combination with isotretinoin. In line with post-consolidation maintenance treatment of high-risk neuroblastoma, this trial will include patients with high-risk neuroblastoma in first complete response. Patients must have completed a multimodal frontline regimen (induction and consolidation) and have achieved complete response (positive bone marrow minimal residual disease as assessed by RTqPCR is allowed) following the multi agent induction and consolidation therapy.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Glycosylation Targeting: A Paradigm Shift in Cancer Immunotherapy.
Ren X, Lin S, Guan F, Kang H. · · 2024 · cited 30× · PMID 38725856 · DOI 10.7150/ijbs.93806 -
The Neuroblastoma Microenvironment, Heterogeneity and Immunotherapeutic Approaches.
Polychronopoulos PA, Bedoya-Reina OC, Johnsen JI. · · 2024 · cited 9× · PMID 38791942 · DOI 10.3390/cancers16101863
Verify or expand the search:
- PubMed search for NCT06047535
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Naxitamab
Trials testing the same drug.
- NCT07011654 — Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC) · Phase 1, PHASE2 · recruiting
- NCT07027748 — Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or R · Phase 1 · recruiting
- NCT06540963 — Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma · Phase 2 · recruiting
- NCT06026657 — Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (D · Phase 1, PHASE2 · recruiting
- NCT05968768 — To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly) · Phase 2 · recruiting
Other recruiting trials for Neuroblastoma
Currently open trials in the same condition.
- NCT07399821 — An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma · Phase 1, PHASE2 · recruiting
- NCT06995872 — Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refra · Phase 1 · recruiting
- NCT06942039 — Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation · EARLY_PHASE1 · recruiting
- NCT07067346 — Safety & Efficacy of IR-101 in Relapsed/Refractory Neuroblastoma · EARLY_PHASE1 · recruiting
- NCT07027748 — Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or R · Phase 1 · recruiting
Other SciClone Pharmaceuticals trials
Trials by the same sponsor.
- NCT07076680 — A Real-World Study in Patients With HR+/HER2- Advanced Breast Cancer · withdrawn
- NCT06548919 — Current Status of Treatment for Chinese Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer · recruiting
- NCT06544577 — Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC · recruiting
- NCT05357196 — PT-112 (Phosplatin's Platinum) Combine With Gemcitabine Injection for Advanced Solid Tumors · Phase 1, PHASE2 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06047535 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SciClone Pharmaceuticals
- Last refreshed: 21 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06047535.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing