RecruitingPhase 1Phase 2NCT05784688

Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid Tumors

A Phase 1b/2a Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of TU2218, an Oral TGFβR Serine/Threonine Kinase Inhibitor, Administered in Combination With Pembrolizumab in Patients With Advanced Solid Tumors


Sponsor

TiumBio Co., Ltd.

Enrollment

140 participants

Start Date

Mar 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study consists of phase 1b and 2a to evaluate safety, Pharmacokinetics, and efficacy of TU2218 in combination with Pembrolizumab in patients with advanced solid tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called TU2218 combined with pembrolizumab (an immunotherapy) in people with advanced solid tumors. TU2218 is designed to block pathways that allow cancer cells to suppress the immune system. The goal is to restore the immune system's ability to recognize and destroy cancer cells. **You may be eligible if:** - You are 18 years old or older with a life expectancy of at least 12 weeks - You have an advanced solid tumor that is not surgically removable and has not responded to or progressed on standard treatments - You have measurable disease and are in good enough health to participate (ECOG 0–1) - You can swallow capsules **You may NOT be eligible if:** - You are not in adequate general health (ECOG 2 or higher) - Your cancer has not progressed on prior PD-1/PD-L1 immunotherapy (for certain phases of the study) - You have conditions preventing you from safely receiving the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTU2218 + KEYTRUDA® (Pembrolizumab)

TU2218: Orally administered KEYTRUDA® (Pembrolizumab): Intravenously administered


Locations(11)

NEXT Oncology

San Antonio, Texas, United States

Hope Cancer Center

Tyler, Texas, United States

Medical Oncology

Spokane, Washington, United States

CHA University Bundang Medical Center

Seongnam, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

The Catholic University of Korea Seoul St. Mary Hospital

Seoul, South Korea

The Catholic University of Korea St. Vincent's Hospital

Suwon, South Korea

View Full Details on ClinicalTrials.gov

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NCT05784688


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