RecruitingPhase 1NCT05130255

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

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


Sponsor

Y-mAbs Therapeutics

Enrollment

60 participants

Start Date

Nov 17, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of targeted radiation treatment that uses a molecule designed to find and attach to a protein called GD2, which is found on certain solid tumors. It delivers a radioactive payload directly to cancer cells. **You may be eligible if...** - You are 18 or older (or 16+ for high-risk neuroblastoma or sarcoma) - Your cancer is known to express the GD2 protein - Your tumor can be measured on a scan - You are in reasonably good health (ECOG 0–1) with expected survival over 3 months - Your blood counts and kidney function meet minimum requirements **You may NOT be eligible if...** - Your tumor cannot be measured - You have poor organ function or severe health issues - You are under 16 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGD2-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(8)

HonorHealth

Scottsdale, Arizona, United States

City of Hope National Medical Center

Duarte, California, United States

University of Chicago

Chicago, Illinois, United States

Corewell Health-BAMF Health

Grand Rapids, Michigan, United States

Memorial Sloan- Kettering Cancer Center

New York, New York, United States

Case Western Reserve University, Cleveland

Cleveland, Ohio, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05130255


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