About the Phase 1 Study of YL-13027
Trial: YL-13027 in Patients With Advanced Solid Tumors
Recruitment Status: Recruiting
Estimated Enrollment: 54 Participants
Summary: 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 is a dose expansion phase to further evaluate the safety, tolerability and preliminary anti-tumor activity of YL-13027 at the RP2D.
Intervention Model Described: Single Group Assignment
ClinicalTrials.gov Identifier: NCT05228600
The first patient has been dosed in the phase 1 clinical study (NCT05228600) of the potent, selective TGFβ receptor 1 (TGFβR1) oral inhibitor, YL-13027, in patients with advanced solid tumors, according to a press release from Yingli Pharma US, Inc.1
YL-13027 works to neutralize TGFβ signaling and enhance immunomodulation in the tumor microenvironment. In previous studies, YL-13027 was deemed safe and well tolerated by patients and demonstrated reliable dose-proportionality and pharmacokinetic properties.
“The TGFβ pathway represents a promising target for cancer therapeutics. As yet, no therapies have been approved that inhibit TGFβR1 signaling,” said Michael Hui, MBA, chief executive officer of Yingli, in the press release. “We are delighted to be opening the clinical study in the US and hope to build on the positive preliminary results seen in the ongoing YL-13027 Phase 1 trial in China with promising pharmacokinetics, safety and preliminary evidence of durable antitumor activity.”
The dose-escalation, multicenter, open-label, phase 1 study has a target enrollment of 54 patients and an estimated study completion date of December 1, 2023. With a 3+3 study design, investigators will evaluate the safety and tolerability of YL-13027 in patients with solid tumors, as well as determine the recommended phase 2 dose.
There will be 2 parts of the study, including dose escalation (part 1) and dose expansion (part 2) portions. Part 1 will consist of 4 cohorts of 3 to 6 patients each who will be treated with YL-13027, and part 2 will further evaluate the safety, tolerability, and preliminary anti-tumor activity of YL-13027 at the recommended phase 2 dose. One cycle is equivalent to 28 days.
Enrollment in the trial is open to individuals aged 18 years and older with advanced solid tumors that are unresectable or metastatic and considered refractory or not eligible for available approved therapies. Patients must have measurable disease with at least 1 lesion amenable to response assessment per RECIST 1.1 criteria, adequate organ function, an ECOG performance status of 0 to 1, and a life expectancy over 12 weeks at baseline.
For women who have childbearing potential, a negative serum or urine pregnancy test is required within 72 hours prior to receiving the administration of YL-13027 for the first time. Additionally, women must be willing to use an adequate method of contraception between 30 days before first administration of the study drug administration to at least 3 months following last day of administration.
As for male patients of childbearing potential, they must be surgically sterile or agree to also use an adequate method of contraception during the study through 3 months following the last day of study drug administration.
Primary end points of the trial include determining the frequency, duration, and severity of adverse events (AEs) and serious AEs. Secondary end points include pharmacokinetics, overall response rate, duration of response, progression-free survival, duration of stable disease, and clinical benefit rate. A further exploratory outcome measure includes plasma tumor antigens examined throughout the study for approximately 2 years.
“We believe that our drug has potential as a monotherapy or in combination with immunotherapies, and we’re excited to advance this therapy and provide patients with advanced solid tumors a convenient oral treatment option,” Hui stated.
The study is actively recruiting patients at The University of Texas MD Anderson Cancer Center in Houston.
References:
Yingli Pharma Doses First US Patient in Phase 1 Study of YL-13027 for Patients with Advanced Solid Tumors. News release. Yingli Pharma US, Inc. Published May 26, 2022. Accessed June 9, 2022. https://bit.ly/3zt65xq
YL-13027 in patients with advanced solid tumors. ClinicalTrials.gov. Accessed June 9, 2022. https://bit.ly/3O6Bt96
