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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Efficacy of TAK-169 in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

2019-07-17 10:04:59 | BioPortfolio

Summary

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.

Description

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.

Study Design

Conditions

Relapsed and/or Refractory Multiple Myeloma

Intervention

TAK-169

Status

Not yet recruiting

Source

Takeda

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-17T10:04:59-0400

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