A Phase 1 Study of GD2-SADA:177Lu-DOTA in People with Sarcoma

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Full Title

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

Purpose

The purpose of this study is to find the best doses and dosing schedules for the investigational drugs GD2-SADA and 177Lu-DOTA when given together in people with advanced sarcoma that has come back or continued to grow despite treatment. GD2-SADA binds to a protein called GD2, which is found in high amounts on some types of cancer. 177Lu-DOTA then binds to GD2-SADA and releases radiation to destroy cancer cells. Both medications are given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have an inoperable or metastatic sarcoma which has come back or continued to grow despite treatment.
  • At least 3 weeks must pass between the completion of previous therapies and receipt of the study treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 16 and older.

Contact

For more information and to ask about eligibility for this study, please contact MSK KIDS at 833-MSK-KIDS and mention your interest in this study.

Protocol

23-029

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

ClinicalTrials.gov ID

NCT05130255