GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2 (NCT05130255) | Clinical Trial Compass
TerminatedPhase 1
GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
Stopped: Decision by Sponsor
United States23 participantsStarted 2022-11-17
Plain-language summary
Patients with Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma will be treated with GD2-SADA:177Lu-DOTA complex(The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA and 177Lu-DOTA) to assess safety and tolerability
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has been terminated and was only in Phase 1 — which focuses on finding safe doses rather than proving the treatment works — what does that mean for my ability to access this type of GD2-targeted approach, and are there other similar studies I might discuss instead?
2This trial was measuring dose-limiting toxicities, meaning researchers were still figuring out how much of this radioactive treatment the body can handle — given that safety data from a terminated Phase 1 study may be incomplete, what is actually known so far about the risks of combining a GD2-targeting agent with lutetium-177 radiation?
3My condition is one of the ones this trial was studying — SCLC, melanoma, sarcoma, or neuroblastoma — so are there currently any other active trials using GD2-targeted therapies or radioimmunotherapy that my care team thinks would be worth exploring for my specific diagnosis?
4Because this trial was terminated before completing, does my doctor know why it was stopped — for example, was it due to safety concerns, funding issues, or something else — and does that reason affect whether a similar treatment approach might still be worth pursuing?
5Given that this was an early-phase, experimental approach involving radioactive treatment in tumors expressing GD2, how does it compare to the standard-of-care options currently available for my specific cancer type, and should we consider those paths first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Dose Limiting Toxicity
Timeframe: Within 6 weeks after first IMP administration