Trial · NCT04167618
177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma
NCT04167618, Phase 1, Phase 2, Terminated, Y-mAbs Therapeutics; results first posted 2023-10-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma. Trials, record NCT04167618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04167618
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma
- NCT number
- NCT04167618
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Y-mAbs Therapeutics
- Conditions
- Medulloblastoma, Childhood
- Interventions
- 177Lu-DTPA-omburtamab
- First posted
- 2019-11-19
- Last updated
- 2023-10-06
- Results first posted
- 2023-10-06
- Limitations and caveats
- The trial was terminated after 2 subjects due to a business strategy decision. At this point the maximum tolerated dose was not established.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Limiting Toxicities (DLTs) Part 1 | Days 1 through 35 in cycle 1 | Summary of DLTs in DLT evaluable subjects. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose Limiting Toxicities (DLTs) Part 1 | Days 1 through 35 in cycle 1 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose Limiting Toxicities (DLTs) Part 1 | 10 mCi 177Lu-DTPA-omburtamab | 0 | Participants | ||
| Dose Limiting Toxicities (DLTs) Part 1 | 25 mCi 177Lu-DTPA-omburtamab | 1 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 10 mCi 177Lu-DTPA-omburtamab | 1 | |
| Overall Study | STARTED | 25 mCi 177Lu-DTPA-omburtamab | 1 | |
| Overall Study | COMPLETED | 10 mCi 177Lu-DTPA-omburtamab | 0 | |
| Overall Study | COMPLETED | 25 mCi 177Lu-DTPA-omburtamab | 0 | |
| Overall Study | NOT COMPLETED | 10 mCi 177Lu-DTPA-omburtamab | 1 | |
| Overall Study | NOT COMPLETED | 25 mCi 177Lu-DTPA-omburtamab | 1 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | 10 mCi 177Lu-DTPA-omburtamab | 0 | 1 | 0 |
| other | Alanine aminotransferase increased | Investigations | 25 mCi 177Lu-DTPA-omburtamab | 1 | 1 | 1 |
| other | Blood albumin decreased | Investigations | 10 mCi 177Lu-DTPA-omburtamab | 0 | 1 | 0 |
| other | Blood albumin decreased | Investigations | 25 mCi 177Lu-DTPA-omburtamab | 1 | 1 | 1 |
| other | Neutrophil count decreased | Investigations | 10 mCi 177Lu-DTPA-omburtamab | 0 | 1 | 0 |
| other | Neutrophil count decreased | Investigations | 25 mCi 177Lu-DTPA-omburtamab | 1 | 1 | 1 |
| other | Platelet count decreased | Investigations | 10 mCi 177Lu-DTPA-omburtamab | 0 | 1 | 0 |
| other | Platelet count decreased | Investigations | 25 mCi 177Lu-DTPA-omburtamab | 1 | 1 | 1 |
| other | White blood cell count decreased | Investigations | 10 mCi 177Lu-DTPA-omburtamab | 0 | 1 | 0 |
| other | White blood cell count decreased | Investigations | 25 mCi 177Lu-DTPA-omburtamab | 1 | 1 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 10 mCi 177Lu-DTPA-omburtamab | 0 | 1 |
| Total, all-cause mortality | 25 mCi 177Lu-DTPA-omburtamab | 0 | 1 |
| Total, other adverse events | 10 mCi 177Lu-DTPA-omburtamab | 0 | 1 |
| Total, other adverse events | 25 mCi 177Lu-DTPA-omburtamab | 1 | 1 |
| Total, serious adverse events | 10 mCi 177Lu-DTPA-omburtamab | 1 | 1 |
| Total, serious adverse events | 25 mCi 177Lu-DTPA-omburtamab | 0 | 1 |
Source ClinicalTrials.gov
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 10 mCi 177Lu-DTPA-omburtamab vs 25 mCi 177Lu-DTPA-omburtamab: Dose Limiting Toxicities (DLTs) Part 1 | Trial comparisons |
| 10 mCi 177Lu-DTPA-omburtamab vs 25 mCi 177Lu-DTPA-omburtamab: deaths from any cause | Trial comparisons |
| 10 mCi 177Lu-DTPA-omburtamab vs 25 mCi 177Lu-DTPA-omburtamab: serious adverse events | Trial comparisons |
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/NCT04167618
GET https://conductscience.org/api/trials/v1/NCT04167618/registered