Testing Experimental Anti-cancer Drug SLC-391 With an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers

Summary

SLC-391 is a novel, potent and specific small molecule inhibitor of receptor tyrosine kinase AXL with desirable potency and pharmaceutical properties. The study is being done to evaluate the safety and pharmacokinetic (PK) profile of SLC-391 in combination with pembrolizumab in participants with non-small cell lung cancer (NSCLC). Each treatment cycle lasts 21 days. Participants will swallow SLC-391 pills two times every day. Participants will get pembrolizumab intravenously (IV) from the study site staff on the first day of every cycle. This study has 2 parts. The first part will determine the recommended dose of SLC-391 in combination with pembrolizumab. The second part wants to find out if the combination of SLC-391 and pembrolizumab can help stop NSCLC tumours from growing or spreading.

Timeline

Start

2023-05-31

Primary completion

2025-12-01

Completion

2025-12-01

Outcome

Outcome not reported

Stopped (Enrollment): “Lack of efficacy and enrollment challenges”

Publications

• Zhang Z, Morrison D, Lu L, Singh M, Yan J, Leighl N, Laurie SA, Hotte S. First-in-Human Phase I Clinical Trial of SLC-391, a Novel and Selective AXL Inhibitor, in Patients with Advanced Solid Tumours. Pharmaceuticals (Basel). 2025 Dec 17;18(12):1898. doi: 10.3390/ph18121898.

Drugs

Indications