A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of Second Mitochondrial-derived Activator of Caspases Mimetic BGB-24714 as Monotherapy and With Combination Therapies in Patients With Solid Tumors

MC #24-20

NCT #
Condition(s)
Solid Tumor
Molecular Target(s)
SMAC
Drug Classification(s)
Molecular Targeted Therapy
Agents(s)
BGB-24714
Phase(s)
I

Mechanism of Action

  • BGB-24714 is a SMAC mimetic

Purpose

In this study, the sponsor and investigators want to learn:

  • How much of the study drug / agent can be given with an acceptable level of side effects
  • The effects of the study drug / agent (good and bad)
  • How much of the study drug / agent is absorbed into the blood and how fast it is removed
  • If research tests can be used in the future to predict who will benefit from BGB-24714

Study Design

This is a dose expansion study. In the dose expansion part of the study, a larger number of people receive the study drug dose determined to be appropriate in the dose escalation part of the study. The dose of the study drug you receive will remain the same while you are receiving the study regimen.

The study regimen will be given in cycles. There are 2 cohorts.
In Cohort 1 – NSCLC, one treatment cycle consists of 21 days.
In Cohort 2 – PROC, one treatment cycle consists of 28 days. Your Study Doctor will inform you when this is applicable to you. If you initially joined the study, in which Cohort 2 was defined as 21-day cycles, you may be asked to switch to the 28-day cycle during your treatment period.

You will receive the study drug by mouth in fasted state with approximately 250 mL of water as a once daily regimen on Days 1 to 5, 8 to 12, and 15 to 19 (5 days on and 2 days off on a weekly basis) of 21-day treatment cycles. You will receive the study drug by mouth in fasted state with approximately 250 mL of water as a once daily regimen on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 (5 days on and 2 days off on a weekly basis) of 28-day treatment cycles.

Location

Mary Crowley Cancer Research - Medical City Dallas

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