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YL-13027 for Solid Tumors
Phase 1
Waitlist Available
Led By Trisha Wi Draper, Ph D
Research Sponsored by Shanghai YingLi Pharmaceutical Co. Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study for approximately 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug called YL-13027 in patients with advanced solid tumors. The goal is to see if the drug is safe and effective in shrinking or stopping tumor growth. Patients in the study have limited treatment options and may not respond well to existing therapies.
Eligible Conditions
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the study for approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study for approximately 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequency, duration and severity of Adverse Events and Serious Adverse Events
Secondary study objectives
Clinical Benefit Rate
DOR
Duration of Stable Disease
+3 moreOther study objectives
Plasma tumor antigens
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: YL-13027Experimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Shanghai YingLi Pharmaceutical Co. Ltd.Lead Sponsor
22 Previous Clinical Trials
2,261 Total Patients Enrolled
Yingli Pharma US, IncUNKNOWN
1 Previous Clinical Trials
55 Total Patients Enrolled
Trisha Wi Draper, Ph DPrincipal InvestigatorUniversity of Cincinnati Cincinnati, OH 45267-0562
Martin E Gutierrez, MDPrincipal InvestigatorHackensack University Medical Center Hackensack, NJ 07601
Ignacio Ga Laguna,, MD, Ph.DPrincipal InvestigatorHuntsman Cancer Institute Salt Lake City, UT 84112
Jordi Ah Rodon, Ph DPrincipal InvestigatorMD Anderson Cancer Center Houston TX 77030
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: YL-13027
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.