Lung Cancer Clinical Trial

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

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

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Full 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.

View Eligibility Criteria

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 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 is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05130255

Recruitment Status:

Recruiting

Sponsor:

Y-mAbs Therapeutics

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There are 6 Locations for this study

See Locations Near You

HonorHealth
Scottsdale Arizona, 85258, United States More Info
Justin Moser, MD
Contact
[email protected]
City of Hope National Medical Center
Duarte California, 91010, United States More Info
Janet Yoon, MD
Contact
[email protected]
Memorial Sloan- Kettering Cancer Center
New York New York, 10065, United States More Info
Emily Slotkin, MD
Contact
[email protected]
Case Western Reserve University, Cleveland
Cleveland Ohio, 44106, United States More Info
Afshin Dowlati, MD
Contact
[email protected]
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15260, United States More Info
Taofeek Owonikoko, MD
Contact
[email protected]
University of Wisconsin-Madison
Madison Wisconsin, 53705, United States More Info
Vincent Ma, MD
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05130255

Recruitment Status:

Recruiting

Sponsor:


Y-mAbs Therapeutics

How clear is this clinincal trial information?

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