YL-13027 for Tumors, Solid

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tumors, Solid+1 More
YL-13027 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Tumors, Solid

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Throughout the study for approximately 2 years

Year 2
Clinical Benefit Rate
DOR
Duration of Stable Disease
Frequency, duration and severity of Adverse Events and Serious Adverse Events
ORR
PFS
Pharmacokinetics
Plasma tumor antigens

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

YL-13027
1 of 1

Experimental Treatment

54 Total Participants · 1 Treatment Group

Primary Treatment: YL-13027 · No Placebo Group · Phase 1

YL-13027
Drug
Experimental Group · 1 Intervention: YL-13027 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: throughout the study for approximately 2 years

Who is running the clinical trial?

Shanghai YingLi Pharmaceutical Co. Ltd.Lead Sponsor
15 Previous Clinical Trials
1,114 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
Ignacio Ga Laguna,, MD, Ph.DPrincipal InvestigatorHuntsman Cancer Institute Salt Lake City, UT 84112
Martin E Gutierrez, MDPrincipal InvestigatorHackensack University Medical Center Hackensack, NJ 07601
Jordi Ah Rodon, Ph DPrincipal InvestigatorMD Anderson Cancer Center Houston TX 77030

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The value of the hematological absolute neutrophil count (ANC) is less than or equal to 1.
The threshold for hepatic total bilirubin is 1.5 times the institutional ULN.
Demonstrate adequate organ function as defined below

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: November 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.