NCT04167618 is a Phase 1, PHASE2 clinical trial of 177Lu-DTPA-omburtamab in Medulloblastoma, Childhood, sponsored by Y-mAbs Therapeutics.

Who is sponsoring NCT04167618?

NCT04167618 is sponsored by Y-mAbs Therapeutics.

What drugs are being tested in NCT04167618?

Interventions in NCT04167618: 177Lu-DTPA-omburtamab.

What condition does NCT04167618 study?

NCT04167618 studies Medulloblastoma, Childhood.

Is NCT04167618 still recruiting?

NCT04167618 is currently terminated. Last updated 6 October 2023.

Are results published for NCT04167618?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-10-06 · How we verify

NCT04167618

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma

Terminated Phase 1, PHASE2 Results posted Last updated 6 October 2023

What this trial tests

Phase 1, PHASE2 trial testing 177Lu-DTPA-omburtamab in Medulloblastoma, Childhood in 2 participants. Terminated before completion.

Timeline

30 September 2021

Primary endpoint
11 August 2022

11 August 2022

Quick facts

Lead sponsor	Y-mAbs Therapeutics
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	30 September 2021
Primary completion	11 August 2022
Estimated completion	11 August 2022
Sites	10 locations across Denmark, Netherlands, United Kingdom, United States, Spain

Drugs / interventions tested

177Lu-DTPA-omburtamab — full drug profile →

Conditions studied

Medulloblastoma, Childhood — all drugs for Medulloblastoma, Childhood →

Sponsor

Y-mAbs Therapeutics — full company profile →

Who can join

Adults 3 to 19, any sex, with Medulloblastoma, Childhood. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Dose Limiting Toxicities (DLTs) Part 1 Primary · Days 1 through 35 in cycle 1

Summary of DLTs in DLT evaluable subjects.

Group	Value	95% CI
10 mCi 177Lu-DTPA-omburtamab	0
25 mCi 177Lu-DTPA-omburtamab	1

Adverse events — posted to ClinicalTrials.gov

Time frame: From 1st dose to 5 weeks after last dose, up to 10 weeks (2 cycles).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

10 mCi 177Lu-DTPA-omburtamab

Serious: 1/1 (100%)

Deaths: 0/1

25 mCi 177Lu-DTPA-omburtamab

Serious: 0/1 (0%)

Deaths: 0/1

Serious adverse events (1 terms)

Reaction	System	10 mCi 177Lu-DTPA-omburtamab	25 mCi 177Lu-DTPA-omburtamab
Partial seizures	Nervous system disorders	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	10 mCi 177Lu-DTPA-omburtamab	25 mCi 177Lu-DTPA-omburtamab
Alanine aminotransferase increased	Investigations	—	—
Blood albumin decreased	Investigations	—	—
Neutrophil count decreased	Investigations	—	—
Platelet count decreased	Investigations	—	—
White blood cell count decreased	Investigations	—	—

Most-reported serious reactions: Partial seizures.

Data from ClinicalTrials.gov NCT04167618 adverse events section.

Sponsor's own description

Children and adolescents diagnosed with medullablastoma and with recurrent or refractory to frontline therapy will be treated with 177Lu-DTPA-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting B7-H3.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

B7-H3: An Attractive Target for Antibody-based Immunotherapy.
Kontos F, Michelakos T, Kurokawa T, Sadagopan A, et al · · 2021 · cited 311× · PMID 33051306 · DOI 10.1158/1078-0432.ccr-20-2584
B7-H3/CD276: An Emerging Cancer Immunotherapy.
Zhou WT, Jin WL. · · 2021 · cited 204× · PMID 34349762 · DOI 10.3389/fimmu.2021.701006
Immune checkpoint of B7-H3 in cancer: from immunology to clinical immunotherapy.
Zhao B, Li H, Xia Y, Wang Y, et al · · 2022 · cited 145× · PMID 36284349 · DOI 10.1186/s13045-022-01364-7
Clinical Insights Into Novel Immune Checkpoint Inhibitors.
Lee JB, Ha SJ, Kim HR. · · 2021 · cited 81× · PMID 34025438 · DOI 10.3389/fphar.2021.681320
Blockade of novel immune checkpoints and new therapeutic combinations to boost antitumor immunity.
Archilla-Ortega A, Domuro C, Martin-Liberal J, Muñoz P. · · 2022 · cited 61× · PMID 35164813 · DOI 10.1186/s13046-022-02264-x
Radioimmunotherapy in Oncology: Overview of the Last Decade Clinical Trials.
Rondon A, Rouanet J, Degoul F. · · 2021 · cited 40× · PMID 34771732 · DOI 10.3390/cancers13215570
Perspectives on metals-based radioimmunotherapy (RIT): moving forward.
White JM, Escorcia FE, Viola NT. · · 2021 · cited 40× · PMID 33995659 · DOI 10.7150/thno.57177
B7-H3 in Brain Malignancies: Immunology and Immunotherapy.
Guo X, Chang M, Wang Y, Xing B, et al · · 2023 · cited 35× · PMID 37564196 · DOI 10.7150/ijbs.85813

Verify or expand the search:

Other recruiting trials for Medulloblastoma, Childhood

Currently open trials in the same condition.

NCT06942039 — Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation · EARLY_PHASE1 · recruiting
NCT06959979 — Novel Molecular Targets and Innovative Therapeutic Perspective in Medulloblastoma · EARLY_PHASE1 · recruiting
NCT06193759 — Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT) · Phase 1 · recruiting
NCT05230758 — Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour · Phase 3 · recruiting
NCT05057702 — Individualized Treatment Plan in Children and Young Adults With Relapsed Medulloblastoma and Ependymoma · NA · recruiting

Other Y-mAbs Therapeutics trials

Trials by the same sponsor.

NCT05994157 — Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Subjects With Relapsed or Refracto · Phase 1 · terminated
NCT04315246 — 177Lu-DTPA-Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors (Breast, NSCLC, Malignant Melan · Phase 1, PHASE2 · withdrawn
NCT05077423 — A Phase 1 Trial of CD33xCD3 BsAb in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · terminated
NCT04560166 — Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma · Phase 2 · terminated
NCT04750239 — Safety and Clinical Activity of Nivatrotamab in Relapsed/Recurrent Metastatic Small-cell Lung Cancer · Phase 1, PHASE2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04167618 (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 Y-mAbs Therapeutics
Last refreshed: 6 October 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/NCT04167618.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing