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

  • STATUS
    Recruiting
  • participants needed
    36
  • sponsor
    Shanghai YingLi Pharmaceutical Co. Ltd.
Updated on 8 August 2022

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.

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- 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.

Details
Condition Advanced Solid Tumors
Treatment YL-13027
Clinical Study IdentifierNCT03869632
SponsorShanghai YingLi Pharmaceutical Co. Ltd.
Last Modified on8 August 2022

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note