← Back to searchRecruitingRecruiting
GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
NCT05130255 · Y-mAbs Therapeutics
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
A phase 1 dose-escalation single-arm, open-label, non-randomized, multi-center trial of the safety and tolerability of GD2-SADA:177Lu-DOTA complex in GD2 expressing solid tumors.
The trial is planned as a Phase 1 trial with three parts, A, B and C. Escalation in this trial will be based on a classical 3+3 trial design.
Part A is a GD2-SADA dose escalation phase, in which patients will receive one treatment cycle.
Part B is a 177Lu-DOTA dose escalation phase, in which patients will receive up to 2 treatment cycles .
Part C is a repeated dosing phase where the doses determined in Part A and B will be administered. Patients will receive repeated treatment cycles with a maximum of 5 cycles.
Eligibility 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
Study design
Enrollment target: 60 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2022-11-17
Estimated completion: 2027-04
Last updated: 2024-10-02
Interventions
Drug: GD2-SADA:177Lu-DOTA Complex
Primary outcomes
- • To determine the optimal, safe GD2-SADA protein dose and dosing interval between GD2-SADA and 177Lu-DOTA administrations (6 weeks)
- • To determine maximum tolerable activity of 177Lu-DOTA (6 weeks)
- • To assess cumulative toxicity signals and safety profile (Number and severity of adverse events) following repeated dosing and determine the recommended phase 2 dose (RP2D) (52 weeks)
Sponsor
Y-mAbs Therapeutics · industry
Contacts & investigators
ContactJoris Wilms · contact · clinicaltrials@ymabs.com · +45 70261414
InvestigatorTaofeek K Owonikoko, MD/PhD · principal_investigator, University of Maryland, Marlene & Steward Greenebaum Comprehensive Cancer Center 22 S Greene St, Baltimore, MD 21201
All locations (8)
HonorHealthRecruiting
Scottsdale, Arizona, United States
City of Hope National Medical CenterRecruiting
Duarte, California, United States
University of ChicagoNot Yet Recruiting
Chicago, Illinois, United States
Corewell Health-BAMF HealthRecruiting
Grand Rapids, Michigan, United States
Memorial Sloan- Kettering Cancer CenterRecruiting
New York, New York, United States
Case Western Reserve University, ClevelandRecruiting
Cleveland, Ohio, United States
UPMC Hillman Cancer CenterActive Not Recruiting
Pittsburgh, Pennsylvania, United States
University of Wisconsin-MadisonRecruiting
Madison, Wisconsin, United States