Actively Recruiting

Phase 1
Age: 16Years +
All Genders
NCT05130255

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

Led by Y-mAbs Therapeutics · Updated on 2024-10-02

60

Participants Needed

8

Research Sites

228 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent from patient or legal guardian as required
  • Age 18 years or older (16 years or older for High Risk Neuroblastoma and Sarcoma) at time of consent
  • Measurable disease based on RECIST 1.1 criteria
  • ECOG performance status of 0 or 1
  • Expected survival greater than 3 months
  • Platelet counts at least 100,000 cells/mm3
  • Hemoglobin at least 9 g/dL
  • Adequate kidney function with serum creatinine 1.5 mg/dL or less or creatinine clearance at least 60 mL/min
  • Ability and willingness to follow the trial protocol
Not Eligible

You will not qualify if you...

  • Chemotherapy, radiotherapy, immunotherapy, or major surgery within 3 weeks before first treatment dose
  • Receiving any other investigational cancer therapy within 3 weeks before first treatment dose
  • Ongoing radiation toxicity from previous radiation therapy
  • Diagnosis of autoimmune disease, immunodeficiency, or active infection with HIV, hepatitis B or C
  • Previous treatment with anti-GD2 antibody

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 8 locations

1

HonorHealth

Scottsdale, Arizona, United States, 85258

Actively Recruiting

2

City of Hope National Medical Center

Duarte, California, United States, 91010

Actively Recruiting

3

University of Chicago

Chicago, Illinois, United States, 60637

Not Yet Recruiting

4

Corewell Health-BAMF Health

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

5

Memorial Sloan- Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

6

Case Western Reserve University, Cleveland

Cleveland, Ohio, United States, 44106

Actively Recruiting

7

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15260

Active, Not Recruiting

8

University of Wisconsin-Madison

Madison, Wisconsin, United States, 53705

Actively Recruiting

Loading map...

Research Team

J

Joris Wilms

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here