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About
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).
Enrollment
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Inclusion criteria
Each participant must meet all of the following inclusion criteria to be enrolled in the study:
Male or female participants 18 years or older.
To be enrolled to the dose escalation (Part A), participants must have
To be enrolled to the dose expansion cohorts (Part B), participants must meet the following criteria:
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Participants must have adequate organ function, including bone marrow reserve, hepatic, renal, pancreatic function and controlled blood pressure as described in the protocol.
Female participants who are postmenopausal for at least 1 year, are surgically sterile, or if of childbearing potential who agree to use 2 effective method(s) of contraception during the study treatment period through 6 months after the last dose of study drug or practice true abstinence.
Male participants, even if surgically sterilized, who agree to practice effective barrier contraception during the study treatment period through 6 months after the last dose of study drug or practice true abstinence.
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Participants must have recovered from the reversible effects of prior anticancer therapy (to Grade less than or equal to (<=) 1).
Exclusion criteria
Participants meeting any of the following exclusion criteria are not to be enrolled in the study.
Primary purpose
Allocation
Interventional model
Masking
143 participants in 9 patient groups
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Data sourced from clinicaltrials.gov
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