Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT03869632
Brief 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.
Study:
NCT03869632
Study Brief:
Protocol Section:
NCT03869632