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The purpose of this study is to evaluate the safety and tolerability of TAK-169, establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and to provide a preliminary evaluation of the clinical activity of TAK-169 monotherapy in participants with RRMM.
The drug being tested in this study is called TAK-169. The study will evaluate the safety, tolerability, preliminary efficacy, PK, pharmacodynamic, and immunogenicity of TAK-169 monotherapy in participants with RRMM.
The study will be conducted in 2 phases: Dose Escalation Phase (Part 1) and an Expansion Phase (Part 2). The study will enroll approximately 81 to 102 participants (39 to 60 participants in Part 1 and approximately 54 participants in Part 2).
In the Dose Escalation Phase (Part 1), the starting dose level will be 50 microgram/kilogram (mcg/kg), once weekly. On the basis of investigator and sponsor review of available safety, PK, pharmacodynamic, and efficacy data from Cohort 1, the dose will be escalated in the subsequent cohorts to 100, 200, 335, 500, and 665 mcg/kg, once weekly. A separate dose escalation may also occur in which TAK-169 will be administered once every 2 weeks.
In the Expansion Phase (Part 2), the study will evaluate two types of RRMM cohorts: Daratumumab-relapsed or Refractory (RR) Cohorts (once weekly and once every 2 weeks TAK-169 administration) and an Anti-CD38 Therapy Naive Cohort (once weekly TAK-169 administration). The starting dose for each expansion cohort will be the MTD/RP2D (once weekly and once every 2 weeks) determined in Part 1 after review of the available safety, efficacy, PK, and pharmacodynamic data from the dose escalation phase of the study.
This multi-center trial will be conducted in the United States. The overall duration of the study is 34 months. Participants will be followed up for 30 days after the last dose of study drug for a follow-up assessment.
Relapsed and/or Refractory Multiple Myeloma
Not yet recruiting
Published on BioPortfolio: 2019-07-17T10:04:59-0400
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An asymptomatic and slow-growing PLASMA CELL dyscrasia characterized by presence of MYELOMA PROTEINS and clonal bone marrow plasma cells without end-organ damage (e.g., renal impairment). It is distinguished from MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE by a much higher risk of progression to symptomatic MULTIPLE MYELOMA.
A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.
Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.
Chronic refractory anemia with granulocytopenia, and/or thrombocytopenia. Myeloblasts and progranulocytes constitute 5 to 40 percent of the nucleated marrow cells.
An abnormal protein with unusual thermosolubility characteristics that is found in the urine of patients with MULTIPLE MYELOMA.
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