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Study of TU2218 with KEYTRUDA® for Advanced Solid Tumors

This study is testing a combination of two drugs, TU2218 and KEYTRUDA® (pembrolizumab), for people with advanced solid tumors, including biliary tract cancer, head and neck squamous cell carcinoma, and colorectal cancer. TU2218 is taken by mouth, and KEYTRUDA® is given intravenously (through a vein). Researchers want to find the best dose of TU2218 to use with KEYTRUDA® and see how well this combination works to shrink tumors. You might be able to join if you are at least 18 years old, have a solid tumor that has progressed or for which standard treatments haven't worked, and have a good general health status. The study aims to measure how many patients respond to the treatment within 24 weeks. The current recruitment status is unclear, and the study plans to enroll 140 participants.

Study design
This is an interventional study with two phases (1b and 2a) that plans to enroll 140 participants. It is designed to evaluate the safety, drug levels in the body (pharmacokinetics), and effectiveness of the drug combination.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures treatment response at 24 weeks, but the duration of follow-up after this is not specified.

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NCT05784688

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
TiumBio Co., Ltd.
~140 participants
Updated 2025-03-30 on ClinicalTrials.gov
What's tested:TU2218 + KEYTRUDA® (Pembrolizumab)

At a glance

Recruiting sites
8 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1b: To determine the Recommended Phase 2 Dose of the Combination (RP2DC) of TU2218 given with Pembrolizumab in selected advanced solid tumors
Measured over During the first 21-day period (Cycle 1)
+1 more outcome measured

Conditions

Solid Tumor
Biliary Tract Cancer
Head and Neck Squamous Cell Carcinoma
Colorectal Cancer

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Where it's being run

11 sites across 3 states
South Korea8
Texas2
Washington1

Study leadership

  • TU2218 · STUDY_DIRECTOR · TiumBio Co., Ltd.

Who to contact

TiumBio Global http://www.tiumbio.com/en/
[email protected]
82-31-600-1500
Email the study team

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Eligibility criteria

Inclusion

ANC ≥1,500 cells/μL
Platelet count ≥100,000/μL
Hemoglobin ≥9.0 g/dL (criteria must be met without packed red blood cell transfusion within the prior 2 weeks. Participants can be on stable dose of erythropoietin \[≥ approximately 3 months\])
International normalized ratio ≤1.5 upper limit of normal (ULN) 11. Adequate hepatic and renal function
Total bilirubin ≤1.5 × ULN
AST and alanine aminotransferase (ALT) ≤2.5 × ULN; if liver metastases are present, then ≤5 × ULN is allowed.
Estimated creatinine clearance ≥60 mL/minute according to the Cockcroft Gault formula. 12. Able to understand and to comply with all protocol requirements, instructions, and restrictions. For Phase 2a, willing and able to provide archival tumor samples or undergo biopsy for biomarker testing during screening. 13. QTcF interval ≤470 msec on screening ECG. 14. Normal ejection fraction (within the reference range of the institution). 15. No concomitant anti-cancer treatments, including experimental agents for 5 half-lives for non-biological agents and a minimum of 4 weeks for any biologics prior to the start of treatment. 16. Resolution of any toxicity to maximum Grade 1 (except alopecia and Grade ≤2 neuropathy) prior to the start of treatment. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement are eligible. 17. Completion of radiotherapy (palliative or curative) at least 14 days prior to the start of treatment with resolution of any toxicity to maximum Grade 1. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. 18. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

What this trial measures

  • Phase 1b: To determine the Recommended Phase 2 Dose of the Combination (RP2DC) of TU2218 given with Pembrolizumab in selected advanced solid tumorsDuring the first 21-day period (Cycle 1)

    At least 1 Dose limiting toxicity (DLT) during Cycle1

  • Phase 2a: To evaluate the efficacy of TU2218 by evaluating the Overall Response rate (ORR) of TU2218 administered in combination with Pembrolizumab in selected advanced solid tumors24 weeks

    ORR is defined as the proportion of patients with a best overall response of Complete response (CR) or Partial response (PR) according to RECIST v1.1 Efficacy analyses will be performed on both PP and ITT Efficacy Analysis Sets.