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

NCT ID: NCT05130255

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-17
• Study Completion Date: 2027-04-30

Brief Summary

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

Detailed Description

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.

Conditions

SCLC; Malignant Melanoma; Sarcoma; High Risk Neuroblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GD2-SADA:177Lu-DOTA Complex

GD2-SADA IV. infusion followed by 177Lu-DOTA IV. infusion (The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA and 177Lu-DOTA ).

1 treatment cycle in Part A, 2 treatment cycles in Part B and up to 5 treatment cycles in Part C

Group Type: EXPERIMENTAL

GD2-SADA:177Lu-DOTA Complex

Intervention Type: DRUG

The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA and 177Lu-DOTA, both will be administered as an IV infusion

Interventions

GD2-SADA:177Lu-DOTA Complex

The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA and 177Lu-DOTA, both will be administered as an IV infusion

Intervention Type: DRUG

Other Intervention Names

two-step radioimmunotherapy

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Y-mAbs Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taofeek K Owonikoko, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

HonorHealth

Scottsdale, Arizona, United States

Site Status: RECRUITING

City of Hope National Medical Center

Duarte, California, United States

Site Status: RECRUITING

University of Chicago

Chicago, Illinois, United States

Site Status: NOT_YET_RECRUITING

Corewell Health-BAMF Health

Grand Rapids, Michigan, United States

Site Status: RECRUITING

Memorial Sloan- Kettering Cancer Center

New York, New York, United States

Site Status: RECRUITING

Case Western Reserve University, Cleveland

Cleveland, Ohio, United States

Site Status: RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status: ACTIVE_NOT_RECRUITING

University of Wisconsin-Madison

Madison, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joris Wilms

Role: CONTACT

clinicaltrials@ymabs.com

+45 70261414

Facility Contacts

Justin Moser, MD

Role: primary

jmoser@honorhealth.com

Janet Yoon, MD

Role: primary

jyoon@coh.org

Aditya Juloori, MD

Role: primary

ajuloori1@bsd.uchicago.edu

David Hoogstra, MD

Role: primary

David.Hoogstra@corewellhealth.org

Emily Slotkin, MD

Role: primary

slotkine@mskcc.org

Afshin Dowlati, MD

Role: primary

Afshin.Dowlati@UHhospitals.org

Vincent Ma, MD

Role: primary

vtma@medicine.wisc.edu

Other Identifiers

1001

Identifier Type: -

Identifier Source: org_study_id