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Safety Study of SLC-391 in Subjects With Solid Tumors

NCT03990454 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-08-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SLC-391

SLC-391 is an AXL inhibitor

Sponsors & Collaborators

  • SignalChem Lifesciences Corporation

    lead INDUSTRY

Principal Investigators

  • Zaihui Zhang, PhD · SignalChem Lifesciences Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03990454 on ClinicalTrials.gov