NCT03869632

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	YL-13027	Daily doses by oral administration on each day of each 28 day cycle. Starting dose is 60mg, with escalation to 360mg, and subsequent dose escalation using a modified Fibonacci algorithm.

Timeline

• Start date: 2019-03-19
• Primary completion: 2021-04-30
• Completion: 2022-06-30
• First posted: 2019-03-11
• Last updated: 2021-11-16

Locations

1 site across 1 country: China