Clinical trial · Interventional
GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
Phase 1 Trial With GD2-SADA:177Lu-DOTA Drug Complex in Patients With Recurrent or Refractory Metastatic Solid Tumors Known to Express GD2, Including Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Decision by Sponsor
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Risk Neuroblastoma | High Risk Neuroblastoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| SCLC | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi) | Drug | — | UNRESOLVED |
| GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi) | Drug | — | UNRESOLVED |
| GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi) | Drug | — | UNRESOLVED |
| GD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi) | Drug | — | UNRESOLVED |
| GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi) | Drug | — | UNRESOLVED |
| GD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi) | Drug | — | UNRESOLVED |
| GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- 0.3 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
- interventionNames
- Drug: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi)
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- 0.3 mg/kg GD2-SADA and 2-day Interval (2 days between GD2-SADA and 177Lu-DOTA)
- interventionNames
- Drug: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi)
- Drug: GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi)
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available