Trial · NCT07549321
A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
NCT07549321, Phase 2, Phase 3, Recruiting, Renaissance Pharma Ltd.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients. Trials, record NCT07549321. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07549321
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
- NCT number
- NCT07549321
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 144 participants, estimated
- Lead sponsor
- Renaissance Pharma Ltd.
- Conditions
- High-Risk Neuroblastoma
- Interventions
- hu1418K322A + Temozolomide + Irinotecan
- First posted
- 2026-04-24
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate (ORR) | Assessed at end of treatment (up to 12 months) | 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) |
| Primary | Metastatic complete response rate (mCRR) | Assessed at end of treatment (up to 12 months) | Proportion of participants treated with hu14.18K322A in combination with chemotherapy who achieve an overall metastatic complete response (mCR) response |
| Secondary | Overall survival (OS) | Up to 3 years | |
| Secondary | Overall Metastatic Response Rate (mORR) | Assessed at end of treatment (up to 12 months) | |
| Secondary | Duration of Response (DOR) | From the time of first response until disease progression, discontinuation from study, start of new therapy, or death | |
| Secondary | Progression-Free Survival (PFS) | From start of Cycle 1 until the first occurrence of progression followed for up to 3 years | |
| Secondary | Event-Free Survival (EFS) | From start of Cycle 1 until the first occurrence of progression, secondary malignancy, or death due to any cause followed for up to 3 years |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07549321
GET https://conductscience.org/api/trials/v1/NCT07549321/registered