Experimental cancer therapy targets tough tumors with radioactive precision
NCT ID NCT05130255
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested a two-step radioimmunotherapy combining GD2-SADA and 177Lu-DOTA in patients with recurrent or metastatic solid tumors, including small cell lung cancer, high-risk neuroblastoma, sarcoma, and melanoma. The goal was to assess safety and find the right dose. The study was terminated early after enrolling 23 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GD2-SADA and 177Lu-DOTA (two-step radioimmunotherapy)
- What this could lead to
- If successful, this could point toward a new treatment option for patients with hard-to-treat cancers that express GD2.
- What could go wrong
- This was an early, terminated Phase 1 trial with only 23 participants, so results are limited. The approach may not prove effective or safe in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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23 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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Mar 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed informed consent from patient, legal guardian(s) and/or adolescents obtained in accordance with local regulations. Pediatric patients must provide assent as required by local regulations. * Age ≥18 years at the time of informed consent, for High Risk Neuroblastoma \& sarcoma age ≥16 years of age at time of informed consent/assent * Measurable disease according to RECIST 1.1 * ECOG performance status 0-1 * Expected survival \>3 months * Platelet counts ≥100,000 cells/mm3 * Hemoglobin ≥9 g/dL * Adequate renal function with serum creatinine ≤1.5 mg/dL or creatinine clearance ≥60mL/min as calculated using the Cockcroft-Gault equation * Patient willing and able to comply with the trial protocol Exclusion Criteria: * Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks prior to the first planned dosing of the IMP per protocol * Patients receiving any other investigational therapy for their cancer within 3 weeks prior to the first planned dosing of the IMP per protocol * Ongoing radiation toxicities from prior RT therapy * Patients with a diagnosis of autoimmune diseases or immunodeficiencies or documented infection with human immunodeficiency virus (HIV) or hepatitis B or C virus (active) * Prior treatment with anti-GD2 antibody
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Case Western Reserve University, Cleveland
Cleveland, Ohio, 44106, United States
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City of Hope National Medical Center
Duarte, California, 91010, United States
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Corewell Health-BAMF Health
Grand Rapids, Michigan, 49503, United States
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HonorHealth
Scottsdale, Arizona, 85258, United States
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Memorial Sloan- Kettering Cancer Center
New York, New York, 10065, United States
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15260, United States
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University of Chicago
Chicago, Illinois, 60637, United States
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University of Wisconsin-Madison
Madison, Wisconsin, 53705, United States
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