Finding studies
Finding studies
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Lead
MEKanistic Therapeutics, Inc.
With
This first-in-human, Phase 1, open-label study will evaluate MTX-531, an investigational small-molecule inhibitor of EGFR and PI3K, as monotherapy in adults with advanced solid tumors. The study will evaluate the safety and tolerability of MTX-531 and determine the maximum tolerated dose (MTD) and provisional recommended Phase 2 dose (RP2D). The study will also characterize the pharmacokinetic (PK) profile of MTX-531 and evaluate its preliminary clinical activity. Safety assessments will include adverse events, dose-limiting toxicities, laboratory assessments, vital signs, and electrocardiograms. Pharmacokinetic assessments will evaluate plasma concentrations and other PK parameters of MTX-531. Anti-tumor activity will be assessed through radiographic tumor evaluations and investigator-assessed response according to RECIST version 1.1. This study represents the first clinical study of MTX-531.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted