A Phase I/II Study of ZN-c3 and Gemcitabine in Adults and Children with Recurrent or Persistent Osteosarcoma

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Full Title

A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination with Gemcitabine in Adult and Pediatric Subjects with Relapsed or Refractory Osteosarcoma

Purpose

The purpose of this study is to: 1) find the highest safe dose of the investigational drug ZN-c3 that can be given in combination with the chemotherapy drug gemcitabine in adults and children with osteosarcoma (bone cancer) that has come back or continued to grow despite treatment, and 2) begin to see if this combination of drugs is useful in slowing the growth of osteosarcoma, since these two drugs may work well together against this cancer.

ZN-c3 blocks WEE1 kinase, a protein that plays an important role in helping cancer cells repair damaged DNA. When WEE1 kinase is blocked, the cancer may stop growing or grow more slowly, and cancer cells may shrink. Zn-c3 is taken orally (by mouth) and gemcitabine is given intravenously (by vein).

Eligibility

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

  • Patients must have recurrent or metastatic osteosarcoma that continues to grow despite prior treatment.
  • Patients should recover from the serious side effects of previous therapies before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 12 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Vishu Avutu at 646-888-6860

Protocol

21-289

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator