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177Lu-DTPA-omburtamab

Phase 1

Recurrent Medulloblastoma | Monoclonal antibody | Oncology |Y-mAbs Therapeutics, Inc.|Last Updated: Jul 13, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as 25 mCi 177Lu- DTPA-omburtamab

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

177Lu-DTPA-omburtamab · 1 trial · 4 indications

Phase 1 1
NCT07698899A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)Recurrent Medulloblastoma
RECRUITING18 Analytics
PHASE1RECRUITING
A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)
Recurrent Medulloblastoma
NCT0769889918
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Study Endpoints

Primary Endpoints

Number of participants with toxicities
Up to 2 cycles (each cycle is 28 days)

To determine safety of up to 2 cycles of cRIT with 177Lu-DTPA-omburtamab treatment in pediatric patients graded according to CTCAE version 5

Maximum Tolerated Dose/MTD
Up to 2 cycles (each cycle is 28 days)

To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of a single injection of cRIT with 177Lu-DTPA-omburtamab in pediatric patients.

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Level 1: 25 mCiEXPERIMENTAL25 mCi 177Lu- DTPA-omburtamab
Dose Level 2: 50 mCiEXPERIMENTAL50 mCi 177Lu- DTPA-omburtamab
Dose Level 3: 75 mCiEXPERIMENTAL75 mCi 177Lu- DTPA-omburtamab
Dose Level 4: 100 mCiEXPERIMENTAL100 mCi 177Lu- DTPA-omburtamab

Interventions

NameTypeDescription
25 mCi 177Lu- DTPA-omburtamabBIOLOGICALThe dose of DTPA-omburtamab will be decided by the dose escalation design
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Eligibility Criteria

Age Range3 Years to 22 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: \- Disease type: * Histologically confirmed diagnosis of a tumor that is known to express B7-H3 including but not limited to neuroblastoma, medulloblastoma, rhabdoid tumors, pineoblastoma, retinoblastoma, CNS embryonal tumor, rhabdomyosarcoma, Ewing's sarcoma and ependymoma. ...

Countries:United States
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