DS-3032b in Subjects with Advanced Solid Tumors or Lymphomas
A Phase 1 Multiple Ascending Dose Study Of DS-3032b, An Oral MDM2 Inhibitor, In Subjects With Advanced Solid Tumors Or Lymphomas
This Phase I research study is for individuals with advanced melanoma or lymphoma. The purpose of this study is to determine and confirm the safety and tolerance of a drug called DS‐3032b at the maximum tolerated dose in the patients enrolled. Preliminary safety and tolerability has been established in Part 1 dose escalation, so Part 2 is to confirm those in the intended population. DS‐3032b is an investigational drug, taken as a capsule, designed to block MDM2‐p53 interaction (a molecular interaction that can help tumor growth). An investigational drug is a medication that is still being studied and has not yet been approved by the United States Food and Drug Administration (FDA). About 40 people will participate in this study. The duration of treatment depends on how the participant's advanced melanoma or lymphoma responds to DS‐3032b.
Are you Eligible? (Inclusion Criteria)
This study will enroll male and female subjects aged 18 years and older with a melanoma or lymphoma that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available.