DS3201-A-J101: A Phase 1 Multiple Ascending Dose Study of DS-3201b in Subjects with Lymphomas

DS3201-A-J101: A Phase 1 Multiple Ascending Dose Study of DS-3201b in Subjects with Lymphomas

Gender
Minimum Age
Maximum Age
Adults
Physicians
Allen, Pamela
Phases
I
Drugs
DS-3201b (1582)
Disease Sites
Non-Hodgkin's Lymphoma
Locations
Winship Cancer Institute of Emory University Winship at Emory Saint Joseph's Hospital
NCT ID
NCT02732275
Protocol Number
DS3201-A-J101
Contact
If interested in learning more about this clinical trial, please contact winshipcto@emory.edu or (404) 778-1868.

Title

DS3201-A-J101: A Phase 1 Multiple Ascending Dose Study of DS-3201b in Subjects with Lymphomas

Summary

Primary Objective: -To evaluate the safety and pharmacokinetics (PK) of multiple-dose monotherapy of DS-3201b and to determine the recommended Phase 2 dose (RP2D) in subjects with non-Hodgkin's lymphoma (NHL) (including adult T-cell leukemia-lymphoma [ATL] and peripheral T-cell lymphoma [PTCL]).

Secondary Objectives: -To determine the maximum tolerated dose (MTD).

-To conduct an evaluation of the antitumor effect of DS-3201b.

Exploratory Objectives: -To conduct an exploratory study of DS-3201b-related biomarkers.

Detail

Primary Objective: -To evaluate the safety and pharmacokinetics (PK) of multiple-dose monotherapy of DS-3201b and to determine the recommended Phase 2 dose (RP2D) in subjects with non-Hodgkin's lymphoma (NHL) (including adult T-cell leukemia-lymphoma [ATL] and peripheral T-cell lymphoma [PTCL]).

Secondary Objectives: -To determine the maximum tolerated dose (MTD).

-To conduct an evaluation of the antitumor effect of DS-3201b.

Exploratory Objectives: -To conduct an exploratory study of DS-3201b-related biomarkers.

Eligibility