Actively Recruiting
Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid Tumors
Led by TiumBio Co., Ltd. · Updated on 2025-03-30
140
Participants Needed
11
Research Sites
299 weeks
Total Duration
On this page
Sponsors
T
TiumBio Co., Ltd.
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adults aged 18 years or older
- Life expectancy of at least 12 weeks
- Measurable disease by RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Ability to swallow capsules
- Histologically or cytologically confirmed advanced unresectable solid tumor with no effective standard therapy or progression after prior treatment
- For prior anti-PD-1/L1 treated patients: received at least 2 doses, showed progression within 16 weeks after last dose
- For head and neck squamous cell carcinoma cohort in phase 2a: anti-PD-(L)1 naive metastatic or unresectable recurrent disease with PD-L1 expression (CPS ≥1) or progressed after platinum chemotherapy
- For biliary tract cancer cohort in phase 2a: locally advanced unresectable or metastatic disease or intolerance to first- and second-line therapies
- For colorectal cancer cohort in phase 2a: anti-PD-(L)1 naive, proficient mismatch repair/microsatellite stable subtype, progressed or intolerant to at least 2 prior chemotherapies
- Adequate blood counts and coagulation parameters
- Adequate liver and kidney function
- Ability to comply with protocol and provide tumor samples for biomarker testing
- QTcF interval ≤470 msec on ECG
- Normal heart ejection fraction
- No concurrent anti-cancer treatments
- Resolution of toxicities to Grade 1 or lower except specified exceptions
- Completed radiotherapy at least 14 days prior with recovery from toxicities
- For females: not pregnant, not breastfeeding, and either not of childbearing potential or using contraception as required
You will not qualify if you...
- Recent myocardial infarction within 6 months or pericardial effusion
- Cardiac or aortic surgery within 12 months
- Unstable angina, stroke, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or arterial disease within 12 months
- Severe congestive heart failure (NYHA class III/IV)
- Major arrhythmias or ECG abnormalities
- Uncontrolled high blood pressure during screening
- High Troponin I levels at screening
- Brain or central nervous system metastases, carcinomatous meningitis, or uncontrolled effusions
- Difficulty swallowing or conditions affecting TU2218 absorption
- Tumors invading major blood vessels or with risk of bleeding
- History of severe bleeding or inability to stop anticoagulant therapy
- Moderate or severe heart valve defects or aneurysms
- Pregnant or breastfeeding females or those unwilling to use birth control
- Prior discontinuation of checkpoint inhibitors due to immune-related adverse events for some cohorts
- Recent systemic anti-cancer therapy or radiotherapy without recovery
- Recent live vaccines or participation in other investigational studies
- History of tissue or organ transplant
- Prior treatment targeting TGF-Beta pathway
- Immunodeficiency or recent immunosuppressive therapy
- Other active malignancies requiring treatment
- Severe hypersensitivity to study drugs or excipients
- Active autoimmune disease requiring systemic treatment
- History or presence of pneumonitis or interstitial lung disease
- Active infections requiring systemic antibiotics or significant infections including HBV, HCV, HIV
- Inability or unwillingness to stop certain medications affecting drug metabolism
- Any serious medical or psychiatric conditions interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
NEXT Oncology
San Antonio, Texas, United States, 78229-3307
Active, Not Recruiting
2
Hope Cancer Center
Tyler, Texas, United States, 75701
Active, Not Recruiting
3
Medical Oncology
Spokane, Washington, United States, 99208
Active, Not Recruiting
4
CHA University Bundang Medical Center
Seongnam, South Korea
Actively Recruiting
5
Seoul National University Bundang Hospital
Seongnam, South Korea
Actively Recruiting
6
Asan Medical Center
Seoul, South Korea
Actively Recruiting
7
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
8
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
9
Severance Hospital
Seoul, South Korea
Actively Recruiting
10
The Catholic University of Korea Seoul St. Mary Hospital
Seoul, South Korea
Actively Recruiting
11
The Catholic University of Korea St. Vincent's Hospital
Suwon, South Korea
Actively Recruiting
Research Team
T
TiumBio Global http://www.tiumbio.com/en/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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