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YL-13027 in Patients With Advanced Solid Tumors

NCT05228600 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-05-20

No results posted yet for this study

Summary

Part 1 (Phase Ia):

This is a dose escalation, 3 + 3 design study, to evaluate the safety and tolerability, and to determine the RP2D of YL-13027 when administered b.i.d. in patients with advanced solid tumors. Up to 4 cohorts of 3-6 patients each will be treated in part 1 of the study. One cycle is 28 days.

Part 2:

This is a dose expansion phase to further evaluate the safety, tolerability and preliminary anti-tumor activity of YL-13027 at the RP2D.

Conditions

Interventions

DRUG

YL-13027

YL-13027 is a novel small molecule TGF-βR1 inhibitor. 1.1.1. Chemical Properties Chemical Name: 6-(5-fluoro-2-(6-methylpyridin-2-yl)phenyl)imidazo\[1,2-a\]pyridine-3-carboxamide Molecular Formula C20H15FN4O Molecular Weight 346.36 Formulation YL-13027 is provided as pink film coated tablets for oral administration in two strengths, 30 mg and 120 mg. Packaging and Storage YL-13027 tablets are packaged (30 tablets/bottle) in the 45 mL opaque HDPE bottles with child resistant polypropylene caps, induction-sealed inner polypropylene liners. YL-13027 tablets should be protected from light in a closed container and stored at room temperature. Stability The shelf-life of YL-13027 oral tablets is tentatively set at 24 months when stored at room temperature.

Sponsors & Collaborators

  • Yingli Pharma US, Inc

    collaborator UNKNOWN

  • Shanghai YingLi Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Jordi Ah Rodon, Ph D · MD Anderson Cancer Center Houston TX 77030

  • Trisha Wi Draper, Ph D · University of Cincinnati Cincinnati, OH 45267-0562

  • Martin E Gutierrez, MD · Hackensack University Medical Center Hackensack, NJ 07601

  • Ignacio Ga Laguna,, MD, Ph.D · Huntsman Cancer Institute Salt Lake City, UT 84112

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-17
Primary Completion
2022-12-30
Completion
2023-12-01
FDA Drug
Yes

Countries

  • United States

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 NCT05228600 on ClinicalTrials.gov