Treatment for solid tumors expressing GD2 using a radioimmunotherapy complex
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
This study is testing a new treatment using a special radioimmunotherapy for patients with solid tumors that have GD2, like certain lung cancers and melanomas, to see if it is safe and effective.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Y-mAbs Therapeutics Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 8 sites (Scottsdale, Arizona and 7 other locations) |
| Trial ID | NCT05130255 on ClinicalTrials.gov |
What this trial studies
This phase 1 trial evaluates the safety and tolerability of the GD2-SADA:177Lu-DOTA complex in patients with solid tumors known to express GD2, including Small Cell Lung Cancer, Malignant Melanoma, Sarcoma, and High Risk Neuroblastoma. The trial consists of three parts: a dose escalation for GD2-SADA, followed by a dose escalation for 177Lu-DOTA, and a repeated dosing phase based on the determined doses. Patients will receive up to five treatment cycles, allowing researchers to assess the therapeutic potential of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older, and adolescents aged 16 and older with measurable GD2-expressing solid tumors and an expected survival of more than three months.
Not a fit: Patients who have received systemic chemotherapy, radiotherapy, immunotherapy, or major surgery within three weeks prior to the trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with GD2-expressing solid tumors.
How similar studies have performed: While this approach is novel, similar radioimmunotherapy strategies have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Scottsdale, Arizona and 7 other locations
- HonorHealth — Scottsdale, Arizona, United States (Recruiting)
- City of Hope National Medical Center — Duarte, California, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Not_yet_recruiting)
- Corewell Health-BAMF Health — Grand Rapids, Michigan, United States (Recruiting)
- Memorial Sloan- Kettering Cancer Center — New York, New York, United States (Recruiting)
- Case Western Reserve University, Cleveland — Cleveland, Ohio, United States (Recruiting)
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Active_not_recruiting)
- University of Wisconsin-Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Taofeek K Owonikoko, MD/PhD — University of Maryland, Marlene & Steward Greenebaum Comprehensive Cancer Center 22 S Greene St, Baltimore, MD 21201
- Study coordinator: Joris Wilms
- Email: clinicaltrials@ymabs.com
- Phone: +45 70261414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.