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YL-13027 for Solid Tumors

MD Anderson Cancer Center, Houston, TX

YL-13027Phase 1RecruitingLed by Trisha Wi Draper, Ph DResearch 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

Measurable disease with at least one lesion amenable to response assessment per RECIST 1.1.

Women of childbearing potential must have negative serum or urine pregnancy test within 72 hours prior to receiving the first study drug administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upthroughout the study for approximately 2 years

Awards & highlights

No Placebo-Only Group

Study Summary

This trial is testing a new drug, YL-13027, to see if it is safe and effective in patients with advanced solid tumors. The first part of the trial (phase Ia) is to determine the best dose of the drug (RP2D) by giving it to a small group of patients. The second part of the trial (phase II) is to expand the study to a larger group of patients to see if the drug has any preliminary anti-tumor activity.

Eligible Conditions

Solid Tumors

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study for approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency, duration and severity of Adverse Events and Serious Adverse Events

Secondary outcome measures

Clinical Benefit Rate

DOR

Duration of Stable Disease

+3 more

Other outcome measures

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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Shanghai YingLi Pharmaceutical Co. Ltd.Lead Sponsor

19 Previous Clinical Trials

1,484 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

Media Library

YL-13027 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05228600 — Phase 1

Solid Tumors Research Study Groups: YL-13027

Solid Tumors Clinical Trial 2023: YL-13027 Highlights & Side Effects. Trial Name: NCT05228600 — Phase 1

YL-13027 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05228600 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum amount of participants that can take part in this research?

"Affirmative. According to clinicaltrials.gov, this study is actively looking for patients - it was first published on May 17th 2022 and most recently edited on the 16th of the same month. 54 people are needed across a single site in order to complete the trial."

Answered by AI

What potential risks come with the use of YL-13027?

"Given the dearth of data on YL-13027's safety and efficacy, we at Power have rated this experimental medication a 1."

Answered by AI

Is enrollment available for this experimental treatment?

"Yes, the information posted on clinicaltrials.gov implies that this trial is still open to applicants. Initially listed on May 17th 2022 and updated most recently on the 16th of May, it requires 54 patients from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

YL-13027 in Patients With Advanced Solid Tumors

2022. "YL-13027 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05228600.