At a glance
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Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AC0010 in Patients With EGFR T790M Positive Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With EGFR TKIs
In Brief
A Phase 2 clinical trial evaluating AC0010 for Metastatic Non-small Cell Lung Cancer. Targeting 368 participants across 17 sites.
Detailed Summary
AC0010 is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral AC0010; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral AC0010; to assess the safety and efficacy of AC0010 in previously treated mutant EGFR in NSCLC patients with EGFR T790M mutation.
Study Details
Timeline
Interventions
Phase 1: AC0010 will be administered in escalating dosages in a period of 28-day cycles. Phase 2: AC0010 will be administered twice-daily at RP2D.