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Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a randomized open-label crossover study comparing the final oral ASTX030 dose to SC azacitidine. The duration of the study is expected to be approximately 48 months.

James Patton, PhD

  • Stevenson Professor of Biological Sciences

Phone

625-322-4738

Email

james.g.patton@Vanderbilt.Edu
2325 Stevenson Center

James Patton, PhD

  • Stevenson Professor of Biological Sciences

625-322-4738

james.g.patton@Vanderbilt.Edu

2325 Stevenson Center

Research Program

Have any questions? Contact Us 1-877-936-8422 for more information

Qiangjun Zhou, Ph.D.

  • Assistant Professor

Phone

37240-7933

Email

qiangjun.zhou@Vanderbilt.Edu
7158C Medical Research Building III
465 21st Avenue South
Nashville, TN 37240-7933

Qiangjun Zhou, Ph.D.

  • Assistant Professor

37240-7933

qiangjun.zhou@Vanderbilt.Edu

7158C Medical Research Building III
465 21st Avenue South
Nashville, TN 37240-7933

Research Program

Have any questions? Contact Us 1-877-936-8422 for more information

Alyssa Hasty, PhD

  • Cornelius Vanderbilt Professor
  • Associate Dean for Faculty, Basic Sciences

Phone

615-322-5177

Email

alyssa.hasty@Vanderbilt.Edu
813 Light Hall

Alyssa Hasty, PhD

  • Cornelius Vanderbilt Professor
  • Associate Dean for Faculty, Basic Sciences

615-322-5177

alyssa.hasty@Vanderbilt.Edu

813 Light Hall

Research Program

Have any questions? Contact Us 1-877-936-8422 for more information
This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.
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