Safety Study of SLC-391 in Subjects With Solid Tumours

Official Title

A Phase 1, Open-label, Dose-escalationStudy of the Safety and Pharmacokinetics of the AXL Inhibitor SLC-391 Administered Orally to Subjects With Solid Tumours

Summary:

SLC-391 is a novel, potent and specific small molecule inhibitor of receptor tyrosine kinase AXL with desirable potency and pharmaceutical properties. It has demonstrated antiproliferative activity against different tumour cell lines in vitro and efficacy in different animal models including nonsmall cell lung cancer (NSCLC), chronic myeloid leukemia (CML) and (acute myeloid leukemia (AML) models. It has also exhibited strong synergy with other approved targeted therapies in different animal models. This is the first clinical study with SLC-391. The goals of this study are to evaluate the safety, pharmacokinetic (PK), and pharmacodynamic profile of SLC-391, and then to identify a safe and pharmacologically active dose for evaluation in subsequent cohorts or clinical studies. In addition, change from baseline of possible blood biomarkers (soluble AXL and Gas 6) may be evaluated. This is an open-label, multicentre, phase 1, dose-escalation, first in human study to evaluate the safety of SLC-391 administered orally (once or twice daily) in 21-day cycles to subjects with advanced solid tumours.

Trial Description

Primary Outcome:

• Number of Participants with Adverse Events (AEs) as assessed by NCI-CTCAE v5.0
• Maximum Tolerated Dose of SLC-391

• Area under the plasma concentration versus time curve (AUC) of SLC-391
• Maximum Observed Plasma Concentration (Cmax)
• Time to the Maximum Observed Plasma Concentration (Tmax)
• Terminal elimination half-life (t1/2)
• Recommended Dose of SLC-391 for future trials
• Preliminary efficacy of SLC-391

View this trial on ClinicalTrials.gov