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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05130255
Other study ID # 1001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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