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Recurrent MedulloblastomaPhase 1NCT07698899

A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)

A Phase 1 study testing 25 mCi 177Lu- DTPA-omburtamab in people with Recurrent Medulloblastoma and Refractory Medulloblastoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to find out whether 177Lu-DPTA-omburtamab is a safe treatment for children and adolescents with recurrent/refractory medulloblastoma or another type of cancer with CNS metastases. Read more about this study

Who is it for?
Ages 3 to 22 years
What is being tested?
25 mCi 177Lu- DTPA-omburtamab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
7 sitesUnited States
Study dates
2 Jul 2026to 2 Jul 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 22 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
  • Disease status:
  • Patients must have recurrent or refractory disease with CNS parenchymal and/or leptomeningeal disease which has been treated with conventional therapies or for which no conventional therapy exists. Measurable or evaluable disease is not required at time of enrollment.
  • Age: Patients must be ≥ 3 and < 22 years of age at the time of enrollment.
  • Prior Therapy: The participant must have recovered from acute toxic effects of prior anti-cancer therapies with the following minimum duration from prior therapy:
Show all 36Show fewer
  • Chemotherapy: Patients must have received their last dose of known myelosuppressive anticancertherapy at least 21 days (3 weeks) prior to enrollment or at least 42 days (6 weeks) if prior nitrosourea.
  • Anti-GD2 monoclonal antibody (neuroblastoma patients): Patients must have received their last dose of anti-GD2 mAb at least 14 days (2 weeks) before enrollment.
  • Radiation: Patients must have had their last fraction of:
  • Craniospinal irradiation, whole brain radiation, or total body irradiation at least 21 days (3 weeks) prior to study enrollment.
  • Focal radiation to areas of symptomatic metastatic disease at least 14 days (2 weeks) prior to study enrollment.
  • Stem Cell Transplant (SCT): For autologous SCT, 60 days (≥ 2 months) must have elapsed before study enrollment. Patients who have received an autologous hematopoietic stem cell injection to support non- myeloablative therapy (such as 131 I-MIBG) are eligible at any time as long as they meet the other criteria for eligibility. 131
  • I-MIBG therapy or treatment with other radiopharmaceuticals (neuroblastoma 131 patients): A minimum of 42 days (6 weeks) must have elapsed after I-MIBG therapy before start of protocol therapy.
  • Investigational/Biologic Agent (anti-neoplastic): Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent ≥ 7 days (1 week) prior to study enrollment.
  • Molecular targeted therapies: Patients must complete a washout period from last therapy that is either 7 days (1 week) or 3 half-lives, whichever is longer.
  • Patients with neurological deficits should have deficits that are stable for a minimum of 7 days (1 week) prior to enrollment.
  • Patients with seizure disorders may be enrolled if seizures are controlled.
  • Karnofsky Performance Scale (KPS for > 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) assessed within 14 days (2 weeks) prior to study enrollment must be ≥ 50%.
  • Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
  • Peripheral absolute neutrophil count (ANC) ≥ 0.5x 109/ L (must not have received G-CSF within 7 days (1 week) prior to enrollment or pegfilgrastim within 14 days (2 weeks) prior to enrollment.
  • Platelet count ≥ 75 x 109/ L. Growth factor support (romiplostim or biosimilar) is permitted both prior to and during therapy.
  • For patients with neuroblastoma (regardless of marrow disease status) and other solid tumors known bone marrow infiltration from disease: platelet count ≥ 50 x 109/ L (with no platelet transfusion within 7 days prior to study enrollment).
  • Adequate Renal Function Defined as:
  • A creatinine based on age/gender as follows: Age; Maximum Serum Creatinine (mg/dL) Male and Female
  • 1 month to < 6 months; 0.4, 0.4 6 months to < 1 year; 0.5, 0.5
  • to < 2 years; 0.6, 0.6
  • to < 6 years; 0.8, 0.8
  • 6 to < 10 years; 1, 1 10 to < 13 years; 1.2. 1.2 13 to < 16 years; 1.5, 1.4
  • ≥ 16 years; 1.7, 1.4
  • The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the CDC.
  • Adequate Liver Function Defined as: - Bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (or ≤ 3 x ULN if Gilbert's syndrome) - SGPT (ALT) < 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
  • Presence of an appropriate intraventricular access device (e.g., programmable ventriculoperitoneal [VP] shunt or Ommaya reservoir). Patients are not required to have an existing programmable VP shunt or Ommaya at the time of study enrollment but must be willing and able to undergo a surgical procedure to have one placed prior to cRIT.
  • Note: Patients with an existing intraventricular VP shunt without a programmable component must be willing and able to undergo modification of the shunt.
  • Patients may have active malignancy outside the central nervous system but do not immediately require treatment for systemic disease. Neuroblastoma patients with CNS and systemic disease will only receive 1 dose of cRIT 177Lu- omburtamab while patients with CNS metastases in the absence of systemic disease can receive 2 doses of cRIT 177Lu-omburtamab.
  • Patients may be on standing steroids, as long as the dosage is either stable or decreasing for at least 7 days (1 week) prior to enrollment.
  • Human Anti-Mouse Antibody (HAMA) testing will be performed prior to 177Lu-DTPAomburtamab.

Who cannot join

  • Patients with obstructive or symptomatic communicating hydrocephalus.
  • Patients with an uncontrolled life-threatening infection.
  • Patients who are pregnant:
  • o A negative pregnancy test is required for all women of childbearing age, and appropriate contraception for 3 months after the last dose of 177Lu-DTPAomburtamab is required during the study period.
  • Severe major organ toxicity:
  • Cardiac, pulmonary, and gastrointestinal system toxicity should all be < grade 2
  • Patients with grade 4 hearing loss are excluded

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sameer Farouk Sait, MBBS contact

212-639-2153

faroukss@mskcc.org

Ravinder Grewal, MD contact

212-639-2872

grewalr@MSKCC.ORG

7 sites in 1 country

United States7 sites, 7 recruiting

  • Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

    Sameer Farouk Sait, MBBS, 212-639-2153

    Recruiting

  • Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)

    Commack, New York, 11725

    Sameer Farouk Sait, MBBS, 212-639-2153

    Recruiting

  • Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

    Sameer Farouk Sait, MBBS, 212-639-2153

    Recruiting

  • Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

    Sameer Farouk Sait, MBBS, 212-639-2153

    Recruiting

  • Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

    Sameer Farouk Sait, MBBS, 212-639-2153

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

    Sameer Farouk Sait, MD, 212-639-2153

    Recruiting

  • Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

    Sameer Farouk Sait, MBBS, 212-639-2153

    Recruiting

Other trials in United States

About this study

Official title: A Phase I Dose Escalation Trial of Compartmental Radioimmunotherapy (cRIT) Using 177Lu-DTPA-omburtamab in Pediatric and Adolescent Patients With Recurrent or Refractory B7H3 Expressing Primary or Metastatic CNS Tumors

The purpose of this study is to find out whether 177Lu-DPTA-omburtamab is a safe treatment for children and adolescents with recurrent/refractory medulloblastoma or another type of cancer with CNS metastases.

Being tested
25 mCi 177Lu- DTPA-omburtamab
Keywords
Recurrent Medulloblastoma, Refractory Medulloblastoma, CNS Metastases, Central Nervous System Metastasis, Memorial Sloan Kettering Cancer Center, 26-097, 177Lu-DTPA-Omburtamab
Medical subject headings
Medulloblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 25 mCi 177Lu- DTPA-omburtamabBiological

    The dose of DTPA-omburtamab will be decided by the dose escalation design

Study groups in NCT07698899
Study groupRoleWhat they receive
Dose Level 1: 25 mCiExperimental25 mCi 177Lu- DTPA-omburtamab
Receives: Biological: 25 mCi 177Lu- DTPA-omburtamab
Dose Level 2: 50 mCiExperimental50 mCi 177Lu- DTPA-omburtamab
Receives: Biological: 25 mCi 177Lu- DTPA-omburtamab
Dose Level 3: 75 mCiExperimental75 mCi 177Lu- DTPA-omburtamab
Receives: Biological: 25 mCi 177Lu- DTPA-omburtamab
Dose Level 4: 100 mCiExperimental100 mCi 177Lu- DTPA-omburtamab
Receives: Biological: 25 mCi 177Lu- DTPA-omburtamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with toxicities

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

    Measured: Up to 2 cycles (each cycle is 28 days)

  2. Maximum Tolerated Dose/MTD

    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.

    Measured: Up to 2 cycles (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start2 Jul 2026
  3. Primary completion2 Jun 2030 (estimated)
  4. Study completion2 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07698899
Sponsor's protocol ID
26-097
Status last verified
Oct 2026
First submitted
6 Jul 2026
Last updated
8 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 25 mCi 177Lu- DTPA-omburtamab in people with Recurrent Medulloblastoma and Refractory Medulloblastoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sameer Farouk Sait, MBBS (212-639-2153, faroukss@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with toxicities (time frame: Up to 2 cycles (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07698899.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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