RECRUITING

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

Conditions

SCLC Malignant Melanoma Sarcoma High Risk Neuroblastoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

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

Quick Facts

Study Start:2022-11-17

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05130255

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.

Ages Eligible for Study:16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Joris Wilms

CONTACT

+45 70261414

clinicaltrials@ymabs.com

Principal Investigator

Taofeek K Owonikoko, MD/PhD

PRINCIPAL_INVESTIGATOR

University of Maryland, Marlene &amp; Steward Greenebaum Comprehensive Cancer Center 22 S Greene St, Baltimore, MD 21201

Study Locations (Sites)

HonorHealth

Scottsdale, Arizona, 85258

United States

City of Hope National Medical Center

Duarte, California, 91010

United States

University of Chicago

Chicago, Illinois, 60637

United States

Corewell Health-BAMF Health

Grand Rapids, Michigan, 49503

United States

Memorial Sloan- Kettering Cancer Center

New York, New York, 10065

United States

Case Western Reserve University, Cleveland

Cleveland, Ohio, 44106

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15260

United States

University of Wisconsin-Madison

Madison, Wisconsin, 53705

United States

Collaborators and Investigators

Sponsor: Y-mAbs Therapeutics

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-17

Study Completion Date2027-04

Study Record Updates

Study Start Date2022-11-17

Study Completion Date2027-04

Terms related to this study

Additional Relevant MeSH Terms

SCLC
Malignant Melanoma
Sarcoma
High Risk Neuroblastoma