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

Sarcoma Clinical Trial

Official title:

Phase 1 Trial With GD2-SADA:177Lu-DOTA Complex in Patients With Recurrent or Refractory Metastatic Solid Tumors Known to Express GD2, Including Small Cell Lung Cancer, Sarcoma and Malignant Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05130255
• Other study ID #: 1001
• Status: Recruiting
• Phase: Phase 1
• Start date: November 17, 2022
• Est. completion date: April 2027

Study information

• Verified date: April 2024
• Source: Y-mAbs Therapeutics
• Contact: Joris Wilms
• Phone: +4570261414
• Email: clinicaltrials[@]ymabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with Small Cell Lung Cancer, 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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 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

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma
• Sarcoma
• SCLC

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	Case Western Reserve University, Cleveland	Cleveland	Ohio
United States	City of Hope National Medical Center	Duarte	California
United States	Corewell Health-BAMF Health	Grand Rapids	Michigan
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Memorial Sloan- Kettering Cancer Center	New York	New York
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	HonorHealth	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Y-mAbs Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the optimal, safe GD2-SADA protein dose and dosing interval between GD2-SADA and 177Lu-DOTA administrations	Occurrence of DLTs (Part A)	6 weeks
Primary	To determine maximum tolerable activity of 177Lu-DOTA	Occurrence of DLTs (Part B)	6 weeks
Primary	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)	Number and severity of adverse events (Part C)	52 weeks