A Phase I Study of NB003 in People with Gastrointestinal Stromal Tumor or Another Solid Tumor

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Full Title

A Multicenter Phase 1, Open-Label Study of NB003 to Assess Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Malignancies

Purpose

The purpose of this study is to find the highest dose of the investigational drug NB003 that can be taken safely in patients with gastrointestinal stromal tumors (GIST) or other solid tumors that have come back, cannot be surgically removed, or spread (metastasized). People with GIST or another solid tumor often have a mutation in the KIT or PDGFR-alpha gene. These genes provide instructions for making proteins that help with cell growth and repair. When they are mutated, the proteins they help produce (the mutated KIT and PDGFR-alpha proteins) may promote cancer growth.

NB003 is designed to target and block the mutant KIT and PDGFR-alpha proteins. This blocking action may help stop cancer cell growth. NB003 is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have GIST or another solid tumor that came back, cannot be surgically removed, or spread.
  • Patients with GIST must have experienced cancer growth despite imatinib or must be unable to tolerate imatinib.
  • Patients should recover from the serious side effects of prior therapies before receiving NB003.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ping Chi at 646-888-4166.

Protocol

21-290

Phase

I

Investigator

Co-Investigators