GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2

Description

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

SCLC, Malignant Melanoma, Sarcoma, High Risk Neuroblastoma

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Study Overview

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Study Details

Study overview

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

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

GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2

Condition
SCLC
Intervention / Treatment

-

Contacts and Locations

Scottsdale

HonorHealth, Scottsdale, Arizona, United States, 85258

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Grand Rapids

Corewell Health-BAMF Health, Grand Rapids, Michigan, United States, 49503

New York

Memorial Sloan- Kettering Cancer Center, New York, New York, United States, 10065

Cleveland

Case Western Reserve University, Cleveland, Cleveland, Ohio, United States, 44106

Pittsburgh

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States, 15260

Madison

University of Wisconsin-Madison, Madison, Wisconsin, United States, 53705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

16 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Y-mAbs Therapeutics,

Taofeek K Owonikoko, MD/PhD, PRINCIPAL_INVESTIGATOR, University of Maryland, Marlene & Steward Greenebaum Comprehensive Cancer Center 22 S Greene St, Baltimore, MD 21201

Study Record Dates

2027-04