Full TitleH3B-8800-G000-101: An Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia
Some cancers grow because of a type of genetic mutation called a “splicing” mutation, resulting in the production of abnormal proteins that promote cancer growth. H3B-8800 is an investigational drug designed to inhibit the splicing that leads to the production of these dysfunctional proteins.
In this study, researchers are finding the highest dose of H3B-8800 that can be given safely in patients with myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), or chronic myelomonocytic leukemia (CMML) that continues to grow despite standard therapies. H3B-8800 is taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have MDS, AML, or CMML that has continued to grow despite standard therapies.
- At least 2 weeks must pass between the completion of prior treatment and entry into 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 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Virginia Klimek at 212-639-6519.