A Phase 1 Multiple Ascending Dose Study Of DS-3032b, An Oral MDM2 Inhibitor, In Subjects With Advanced Solid Tumors Or Lymphomas

Protocol: 
AAAN4003
Phase: 
I

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 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)

1)Patients must be at least 18 years old.
2)Patients must have a histologically or cytologically documented advanced solid tumor or lymphoma that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available.
3) Subjects (male and female) of childbearing/reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse during the study and for 90 days after the last dose of study drug.

Additional Criteria for Study Expansion:
1) Histologically or cytologically documented advanced melanoma or DLBCL with measurable disease that is refractory to standard treatment or for which no standard treatment is available.

Exclusion Criteria:
1) Patients cannot have a history of primary central nervous system malignancy.
2) Patients cannot have a tumor which contains a nonsynonymous mutation, insertion, or deleation in the TP53 gene previously determined at screening.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States