Last updated on November 2019

Study to Assess Safety Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects With Locally Advanced or Metastatic Solid Tumors

Brief description of study

This study is to evaluate the safety, efficacy and clinical activity of BGB-290 and temozolomide (TMZ) in subjects with locally advanced or metastatic solid tumors.

Detailed Study Description

This is an open-label study of BGB290 and temozolomide (TMZ) with a dose escalation and dose expansion phase. Dose escalation will evaluate safety, tolerability, preliminary efficacy, and PK and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) for the two drug combination. It is a modified 3+3 dose escalation scheme with a fixed dose of BGB290 in combination with escalating doses of TMZ. Dose expansion will evaluate the safety, PK profile and anti-tumor activity of BGB-290 and TMZ at a dose/schedule selected from the dose escalation phase. Five different solid malignancy types (n=100) will be evaluated.

Clinical Study Identifier: NCT03150810

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