A Phase IB Study of AVB-S6-500 Combined with Cabozantinib in People with Advanced Kidney Cancer

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Full Title

A Phase 1b/2 Randomized, Study of AVB-S6-500 in Combination with Cabozantinib Versus Cabozantinib Alone in Patients with Advanced Clear Cell Renal Cell Carcinoma Who Have Received Front-Line Treatment

Purpose

The purpose of this study is to find the highest dose of the investigational drug AVB-S6-500 that can be given safely with cabozantinib in people with metastatic kidney cancer that has continued to grow despite initial treatment. AVB-S6-500 is designed to inhibit the activity of proteins that promote kidney cancer growth. Cabozantinib is already used to treat kidney cancer. AVB-S6-500 is given intravenously (by vein) and cabozantinib 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 metastatic clear cell renal cell carcinoma that has continued to grow despite initial therapy.
  • At least 2 weeks must pass since completion of previous chemotherapy or radiation therapy and receipt of the study treatment. Prior cabozantinib treatment is not permitted.
  • 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. Neil Shah at 646-422-4468.

Protocol

21-119

Phase

I/II

Investigator

Co-Investigators