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First in Human Dose Escalation Study of YL-13027 in Subjects With Advanced Stage Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:
First in Human Dose Escalation Study of YL-13027 Monotherapy in Subjects With Advanced Stage Solid Tumors

Clinical Trial Summary

YL-13027-001 is a phase I open-label, first in human, dose escalation study which investigate the tolerability, safety, pharmacokinetics (PK) and efficacy of YL-13027 in subjects with advanced stage solid tumors.

Clinical Trial Description

This is a open-label, single-center, dose-escalation, phase I study of YL-13027 comprised of a dose escalation part and a dose expansion part in subjects with advanced stage solid tumors. The study will investigate the tolerability, safety, pharmacokinetics (PK) and efficacy of YL-13027, and will define the maximum tolerated dose (MTD) of YL-13027 using an accelerated titration test and 3+3 design. a dose expansion part will identify the recommended phase 2 dose. YL-13027 is an orally bioavailable small molecule that inhibits protein serine/threonine kinase of activin receptor-like kinase 5 (ALK5) and blocks intracellular signaling of TGF-β by inhibiting the phosphorylation of ALK5 substrates. In this clinical trial, YL-13027 is given orally daily. A treatment cycle is defined as 28 days. Adverse events (AEs) were graded by NCI-CTCAE V5.0. Efficacy was evaluated according to RECIST V1.1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03869632
Study type Interventional
Source Shanghai YingLi Pharmaceutical Co. Ltd.
Contact Hanying Bao, MD,PhD
Phone 86 21-51370693
Email hybao@yl-pharma.com
Status Recruiting
Phase Phase 1
Start date March 19, 2019
Completion date June 30, 2022
View Details
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