NCT07537400 Naxitamab High Risk Neuroblastoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07537400 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 13 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07537400 is a hot trial to watch
High Risk Neuroblastoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07537400 is notable because it evaluates Naxitamab in a Phase 2 design sponsored by Shaare Zedek Medical Center. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07537400 |
| Official title | Patients Between the Ages of 12 Months to 21 Years With Newly-Diagnosed High-Risk Neuroblastoma Will Receive Children's Oncology Group (COG) Type Recommended Therapy With the Addition of Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to Induction Cycles 1-5 |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Naxitamab |
| Sponsor | Shaare Zedek Medical Center |
| Geography | Israel |
| Enrollment | [object Object] |
| Primary endpoint | Evaluate the safety of chemoimmunotherapy with Naxitamab and COG-type induction chemotherapy in newly diagnosed patients with high-risk neuroblastoma |
| Endpoint time frame | Post 2nd course, and post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months) |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This clinical trial will evaluate the safety of chemoimmunotherapy with Naxitamab and COG-type induction chemotherapy in newly-diagnosed patients with high-risk neuroblastoma. We aim to recruit 10 patients over the next 2 years.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across Israel shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Evaluate the safety of chemoimmunotherapy with Naxitamab and COG-type induction chemotherapy in newly diagnosed patients with high-risk neuroblastoma (Post 2nd course, and post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months)) — This measure will be assessed by evaluating treatment side effects.
- Assess end-of-induction (EOI) response rates following concurrent Naxitamab and induction chemotherapy in newly diagnosed patients with high-risk neuroblastoma. (Post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months)) — This measure will be assessed using the 1993 International Neuroblastoma Response Criteria (INRC) criteria.
- Assess end-of-induction (EOI) response rates following additional cycles of Irinotecan-Temodar-Naxitamab-GM-CSF in patients with high risk neuroblastoma and less than partial response (PR) after induction with COG type chemotherapy and Naxitamab (Post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months))
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
Build a living trial monitor: connect to PatSnap MCP Servers and track recruitment, endpoint revisions, projected readouts and new result records without manually reconciling separate databases.
Asset and sponsor context
Drug & Asset MCP profile: Naxitamab is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Shaare Zedek Medical Center is resolved to a normalized organization record in Israel. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07537400 provides a focused lens on High Risk Neuroblastoma development. Its value will be determined by whether Naxitamab can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
Ready to reproduce this analysis? Explore PatSnap MCP Servers and combine Clinical Trials, Drug & Asset, and Company & Deal Intelligence as reusable building blocks for trial monitoring and SEO-ready clinical reports.
