Who is eligible for clinical trial NCT05204862?

Participants must meet the protocol's inclusion criteria for Advanced Solid Tumor. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05204862 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

Phase 1/2 Study of TU2218 Alone and in Combination With Checkpoint Inhibitors in Patients With Advanced Solid Tumors (NCT05204862)

A Phase 1/2 Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TU2218, an Oral TGFβR Inhibitor, Administered Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: TiumBio Co., Ltd.

🩺 Plain-English Summary (8th-Grade Level)

This study consists of Part A for monotherapy and Part B for combination therapy to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy of TU2218 in patients with advanced solid tumors. The main purpose of Phase 1 is to determined the recommended Phase 2 dose (RP2D) of TU2218 and the main purpose of Phase 2 is to evaluate the antitumor activity of TU2218 at RP2D.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (22 items) and avoid the listed exclusions (33 items).

Location: NEXT Oncology — San Antonio, Texas

Age range: 18 Years

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Myocardial infarction within 6 months prior to screening, or pericardial effusion.
History of cardiac or aortic surgery within 6 months prior to screening.
Unstable angina pectoris, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism; deep venous thrombosis; arterial occlusive disease in the past 12 months.
Congestive heart failure of New York Heart Association class III/IV.
Major arrhythmia or abnormalities identified by ECG per Investigator's judgment.
Uncontrolled hypertension (as defined by systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg) during the screening period.
Elevated troponin 1 levels (Grade 3) at screening or known to have persistently elevated brain natriuretic peptide.
Active and clinically significant bacterial, fungal, or viral infection, including active or known history of hepatitis B virus (defined as hepatitis B surface antigen \[HbsAg\] reactive), or known active hepatitis C virus (defined as hepatitis C virus ribonucleic acid \[qualitative\] is detected), known human immunodeficiency virus or acquired immunodeficiency syndrome related illness. However, an inactive hepatitis B virus carrier can be enrolled
Current or history of interstitial pneumonitis.
Uncontrolled metastatic disease to the brain or central nervous system, massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis, and over 50% liver involvement that is at the discretion of the Investigator. Note: Pleural effusion should be defined by Investigator's discretion.
Known history of difficulty swallowing, malabsorption or other conditions that may reduce absorption of the product.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

NEXT Oncology — San Antonio, Texas
Seoul National University Hospital — Seoul,
Asan Medical Center — Seoul,

📞 Contact the Study Coordinator

Phone: 82-31-600-1500

Email: nce401_tu2218@tiumbio.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗