A Study of TAK-659 in Adult Participants With Advanced Solid Tumor and Lymphoma Malignancies

Summary

This study is an open-label, multicenter, phase 1, dose escalation study of TAK-659 in adult participants with advanced solid tumor and lymphoma malignancies. This study will be the first to administer TAK-659 to humans. The participants population during dose escalation (Part A) will consist of adults previously diagnosed with any form of a solid tumor or lymphoma for which standard, curative, or life-prolonging treatment does not exist or is no longer effective. This first-in-human (FIH) study will include 5 dose expansion cohorts in refractory and/or relapsed Chronic Lymphocytic Leukemia (CLL), Diffuse Large B Cell Lymphoma (DLBCL), indolent Non Hodgkin Lymphoma (iNHL), Mantle Cell Lymphoma (MCL), Post Transplant Lymphoproliferative Disorder (PTLD) (Part B) following completion of dose escalation (Part A).

Timeline

Start

2013-12-31

Primary completion

2021-06-29

Completion

2021-06-29

Publications

• Gordon LI, Karmali R, Kaplan JB, Popat R, Burris HA 3rd, Ferrari S, Madan S, Patel MR, Gritti G, El-Sharkawi D, Chau FI, Radford J, de Oteyza JP, Zinzani PL, Iyer SP, Townsend W, Miao H, Proscurshim I, Wang S, Katyayan S, Yuan Y, Zhu J, Stumpo K, Shou Y, Carpio C, Bosch F. Spleen tyrosine kinase/FMS-like tyrosine kinase-3 inhibition in relapsed/refractory B-cell lymphoma, including diffuse large B-cell lymphoma: updated data with mivavotinib (TAK-659/CB-659). Oncotarget. 2023 Jan 26;14:57-70. doi: 10.18632/oncotarget.28352.
• Gordon LI, Kaplan JB, Popat R, Burris HA 3rd, Ferrari S, Madan S, Patel MR, Gritti G, El-Sharkawi D, Chau I, Radford JA, Perez de Oteyza J, Zinzani PL, Iyer S, Townsend W, Karmali R, Miao H, Proscurshim I, Wang S, Wu Y, Stumpo K, Shou Y, Carpio C, Bosch F. Phase I Study of TAK-659, an Investigational, Dual SYK/FLT3 Inhibitor, in Patients with B-Cell Lymphoma. Clin Cancer Res. 2020 Jul 15;26(14):3546-3556. doi: 10.1158/1078-0432.CCR-19-3239. Epub 2020 Apr 23.

Drugs

Indications