Advanced Malignant Solid Tumors Clinical Trial
Official title:
A Phase 1, Open-Label, Multicenter, Dose Escalation Study to Assess the Safety and Tolerability of MLN7243, an Inhibitor of Ubiquitin-Activating Enzyme (UAE), in Adult Patients With Advanced Solid Tumors
The purpose of this study is to evaluate safety and tolerability (establish maximum tolerated dose [MTD], inform the recommended phase 2 dose [RP2D], and identify the dose-limiting toxicities [DLTs]) of MLN7243.
This is a single arm Phase I study with multiple dosing cohorts as noted below:
- Schedule A: MLN7243 1 mg
- Schedule A: MLN7243 2 mg
- Schedule A: MLN7243 4 mg
- Schedule A: MLN7243 8 mg
- Schedule A: MLN7243 12 mg
- Schedule A: MLN7243 18 mg
- Schedule A: MLN7243 Homozygous Mutant 4 mg
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