Solid TumorPhase 1/2NCT05784688
Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid Tumors
A Phase 1/2 study testing TU2218 + KEYTRUDA® (Pembrolizumab) in people with Solid Tumor and Biliary Tract Cancer, run by TiumBio Co., Ltd. at 11 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Biliary Tract Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- TU2218 + KEYTRUDA® (Pembrolizumab)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 10 Mar 2023to Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and females ≥18 years of age
- Life expectancy ≥12 weeks as judged by the Investigator
- Measurable disease as defined by RECIST v1.1
- ECOG 0 or 1
- Able to swallow capsules
- For Phase 1b and 2a: histologically or cytologically documented advanced unresectable solid tumor for which no effective standard therapy exists, or that has progressed on or not tolerated prior standard therapy. If previously treated with an anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies, PD-1 treatment progression is defined by meeting all of the following criteria:
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- Has received at least 2 doses of an approved anti-PD-1/L1 mAb
- Has demonstrated clinical progression after anti-PD-1/L1 mAb therapy
- Progressive disease has been documented within 16 weeks from the last dose of anti-PD-1/L1 mAb
- For HNSCC cohort in Phase 2a: anti-PD-(L)1 agent-naïve metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death ligand 1 (PD - L1) [combined positive score (CPS) ≥1] as determined by an FDA-approved test Or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy (as applicable).
- For BTC cohort in Phase 2a: biliary tract cancer that has been locally advanced unresectable or metastatic or not tolerated prior standard first line chemotherapy and second line targeted therapy (as applicable).
- For CRC cohort in Phase 2a: anti-PD-(L)1 agent-naïve colorectal adenocarcinoma of Proficient Mismatch Repair (pMMR)/Microsatellite Stable (MSS) subtype, as determined by an FDA-approved test, that has progressed on or not tolerated at least 2 lines of prior standard chemotherapy with biological agents where applicable. Patients with liver metastasis from primary CRC, as confirmed by RESIST v1.1, will be excluded from Phase 2a CRC cohort.
- Adequate hematological function and coagulation defined by
- 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)
- 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.
- 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.
- QTcF interval ≤470 msec on screening ECG.
- Normal ejection fraction (within the reference range of the institution).
- 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.
- 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.
- 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.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) defined as all female after puberty unless they are postmenopausal for at least 1 year or are surgically sterile (hysterectomy or bilateral oophorectomy or tubal ligation).
- A WOCBP who has a negative serum pregnancy test within 3 days of the first administration of study treatment and agrees to follow contraceptive guidance during the treatment period and for at least 30 days after the last dose of TU2218 or until at least 120 days after the last administration of pembrolizumab, whichever comes later.
Who cannot join
- Myocardial infarction within 6 months prior to screening, or pericardial effusion
- History of cardiac or aortic surgery within 12 months
- 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 judgement
- Uncontrolled hypertension (as defined by systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg) during the Screening Period.
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- Elevated Troponin I levels (Grade 3) at screening
- Metastatic disease to the brain or central nervous system, carcinomatous meningitis, massive uncontrolled effusions (pleural, pericardial, peritoneal), and pulmonary lymphangitis
- Known history of difficulty swallowing, malabsorption or other conditions that may reduce absorption of TU2218
- Tumor that compresses or invades major blood vessels or tumor cavitation that in the opinion of the Investigator is likely to bleed
- History of severe bleeding. Unable to stop anticoagulation therapy with heparin, low molecular weight heparin, vitamin K antagonists, anti-platelet agents, or factor Xa inhibitors throughout the study and for at least 28 days post the last dose of study treatment
- Moderate or severe heart valve function defect including moderate or severe valve stenosis or regurgitation
- Evidence or history of septal aneurysm, other heart aneurysm, or any aneurysm of the major vessels
- Female participants must not be pregnant or at risk of becoming pregnant during the study. Fertile male and female participants must agree to use a highly effective method of birth control to avoid pregnancy (for female participants a double-barrier method of contraception, for male participants a condom with spermicide) or total abstinence from the time of providing informed consent until at least 30 days after the last dose of TU2218 or until at least 120 days after the last administration of Pembrolizumab, whichever comes later.
- Female participants who are breastfeeding
- For Phase 1b and BTC cohort in Phase 2a: discontinued prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137), due to an irAE.
- For CRC and HNSCC cohorts in Phase 2a: received prior therapy with an anti-PD-1, anti PD-L1, or anti PD-L2 agent or an agent directed to another stimulatory or co inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to treatment.
- Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy are eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement are eligible.
- Note: If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention.
- Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis.
- Note: Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
- Has received or planned to receive any live or live-attenuated vaccine (e.g., measles, mumps, rubella or chickenpox) within 30 days prior to the first drug administration and while participating the study.
- Note: Administration of killed vaccines are allowed. Receipt of mRNA vaccine, including Coronavirus disease-2019 (COVID-19) vaccine, within 7 days prior to drug administration on Day 1 and during the first 2 cycles of study treatment will not be allowed
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent
- Has had an allogeneic tissue/solid organ transplant
- Received prior treatment targeting the signaling pathway of TGF-Beta
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of bladder, that have undergone potentially curative therapy are not excluded
- Has severe hypersensitivity (Grade ≥3) to Pembrolizumab and/or any of its excipients
- Has an active autoimmune disease or history of autoimmune disease, except vitiligo, hypothyroidism or resolved childhood asthma/atopy, that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic antibiotic therapy
- Active and clinically significant bacterial, fungal, or viral infection, including known history of hepatitis B virus (HBV), known hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness.
- Note: No testing for HBV, HCV, and HIV is required unless mandated by local healthy authority
- Unable or unwilling to stop use of strong inhibitors of cytochrome P450 (CYP)1A2, 2C8 and 3A4, and strong inhibitors of P-gP and breast cancer resistance protein (BCRP) at least 8 days prior to and during study treatment in all Phase 1b dose escalation cohorts
- Unable or unwilling to stop use of gastric pH elevating agents including proton pump inhibitors, H2-receptor antagonists and antacids at least 8 days prior to and during study treatment in all Phase 1b dose escalation cohorts
- Has a history or current evident of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating Investigator
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
- Known history, or suspected hypersensitivity to any excipients of the clinical study treatments
- Any other serious medical condition which in the Investigator's opinion would preclude safe participation in the study
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
South Korea8 sites, 8 recruiting
- Recruiting
CHA University Bundang Medical Center
Seongnam
Hong Jae Chon
- Recruiting
Seoul National University Bundang Hospital
Seongnam
Jin Won Kim
- Recruiting
Asan Medical Center
Seoul
Sung-Bae Kim
- Recruiting
Samsung Medical Center
Seoul
Joon Oh Park
- Recruiting
Seoul National University Hospital
Seoul
Do-Youn Oh
- Recruiting
Severance Hospital
Seoul
Hye Ryun Kim
- Recruiting
The Catholic University of Korea Seoul St. Mary Hospital
Seoul
Myung-Ah Lee
- Recruiting
The Catholic University of Korea St. Vincent's Hospital
Suwon
Ho-Jung An
United States3 sites
- Active, not recruiting
NEXT Oncology
San Antonio, Texas, 78229-3307
- Active, not recruiting
Medical Oncology
Spokane, Washington, 99208
- Active, not recruiting
Hope Cancer Center
Tyler, Texas, 75701
About this study
Official title: 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
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.
Read the detailed description
The primary objective of phase 1b is to determine the recommended phase 2 dose of the combination (RP2DC) of TU2218 given with pembrolizumab in advanced solid tumors.
The primary objective of phase 2a is to evaluate the efficacy of TU2218 administered in combination with pembrolizumab in selected advanced tumors.
- Conditions
- Solid Tumor, Biliary Tract Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer
- Being tested
- TU2218 + KEYTRUDA® (Pembrolizumab)
- Medical subject headings
- Biliary Tract Neoplasms, Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TU2218 + KEYTRUDA® (Pembrolizumab)Drug
TU2218: Orally administered KEYTRUDA® (Pembrolizumab): Intravenously administered
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b: TU2218 + KEYTRUDA® (Pembrolizumab) in solid tumor | Experimental | TU2218 orally and KEYTRUDA® (Pembrolizumab) intravenously administered daily for two weeks followed by one week to determine RP2DC. Receives: Drug: TU2218 + KEYTRUDA® (Pembrolizumab) |
| Phase 2a: TU2218 + KEYTRUDA® (Pembrolizumab) in Biliary Tract Cancer (BTC) | Experimental | TU2218 + KEYTRUDA® (Pembrolizumab) administered, orally BID, for 2 weeks followed by 1 week of rest in 3-week cycles for TU2218 and intravenous 200mg once every 3 weeks for KEYTRUDA® (Pembrolizumab) Receives: Drug: TU2218 + KEYTRUDA® (Pembrolizumab) |
| Phase 2a: TU2218 + KEYTRUDA® (Pembrolizumab) in Head and Neck Squamous Cell Carcinoma (HNSCC) | Experimental | TU2218 + KEYTRUDA® (Pembrolizumab) administered, orally BID, for 2 weeks followed by 1 week of rest in 3-week cycles for TU2218 and intravenous 200mg once every 3 weeks for KEYTRUDA® (Pembrolizumab) Receives: Drug: TU2218 + KEYTRUDA® (Pembrolizumab) |
| Phase 2a: TU2218 + KEYTRUDA® (Pembrolizumab) in ColoRectal Cancer (CRC) | Experimental | TU2218 + KEYTRUDA® (Pembrolizumab) administered, orally BID, for 2 weeks followed by 1 week of rest in 3-week cycles for TU2218 and intravenous 200mg once every 3 weeks for KEYTRUDA® (Pembrolizumab) Receives: Drug: TU2218 + KEYTRUDA® (Pembrolizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: To determine the Recommended Phase 2 Dose of the Combination (RP2DC) of TU2218 given with Pembrolizumab in selected advanced solid tumors
At least 1 Dose limiting toxicity (DLT) during Cycle1
Measured: During the first 21-day period (Cycle 1)
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 tumors
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.
Measured: 24 weeks
Secondary outcomes (7)
Phase 1b and 2a: To further evaluate the safety and tolerability of TU2218 administered in combination with pembrolizumab.
Incidence and severity of TEAEs, Incidence of Serious Adverse Events (SAE), Treatment Related Adverse Events (TRAE), and Adverse Events of Special Interest (AESI).
Measured: approximately 13 months
Phase 1b and 2a: The PK of TU2218 administered in combination with pembrolizumab
TU2218 plasma concentration
Measured: Cycle 1 (each cycle is 21 days)
Time to Progression (TTP)
TTP is defined as the time from first dose of study treatment to the date of first documented PD.
Measured: over 24 weeks
Duration of Response (DoR)
DoR is defined as the duration between first documentation of CR or PR to first documentation of PD or death.
Measured: over 24 weeks
Disease Control Rate (DCR)
DCR is defined as the proportion of participants with a best overall response of CR or PR or stable disease (SD)
Measured: over 24 weeks
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of participants with response or stabilization
Measured: over 24 weeks
Overall Survival (OS)
OS time is defined as the time from the date of first dose of study treatment to the date of death due to any cause.
Measured: OS rate at 6 months = up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start10 Mar 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TiumBio Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- TU2218, Study director, TiumBio Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784688
- Sponsor's protocol ID
- TUC1PI-02
- Other IDs
- MK-3475-E34
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We will make our final decision after EOP2 meeting.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05784688
- Acronym / sponsor ID
- TUC1PI-02
- Conditions
- Solid Tumor, Biliary Tract Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- TiumBio Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of phase 1b is to determine the recommended phase 2 dose of the combination (RP2DC) of TU2218 given with pembrolizumab in advanced solid tumors.
The primary objective of phase 2a is to evaluate the efficacy of TU2218 administered in combination with pembrolizumab in selected advanced tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1b: TU2218 + KEYTRUDA® (Pembrolizumab) in solid tumor | Experimental | Drug: TU2218 + KEYTRUDA® (Pembrolizumab)TU2218 orally and KEYTRUDA® (Pembrolizumab) intravenously administered daily for two weeks followed by one week to determine RP2DC. |
| Phase 2a: TU2218 + KEYTRUDA® (Pembrolizumab) in Biliary Tract Cancer (BTC) | Experimental | Drug: TU2218 + KEYTRUDA® (Pembrolizumab)TU2218 + KEYTRUDA® (Pembrolizumab) administered, orally BID, for 2 weeks followed by 1 week of rest in 3-week cycles for TU2218 and intravenous 200mg once every 3 weeks for KEYTRUDA® (Pembrolizumab) |
| Phase 2a: TU2218 + KEYTRUDA® (Pembrolizumab) in Head and Neck Squamous Cell Carcinoma (HNSCC) | Experimental | Drug: TU2218 + KEYTRUDA® (Pembrolizumab)TU2218 + KEYTRUDA® (Pembrolizumab) administered, orally BID, for 2 weeks followed by 1 week of rest in 3-week cycles for TU2218 and intravenous 200mg once every 3 weeks for KEYTRUDA® (Pembrolizumab) |
| Phase 2a: TU2218 + KEYTRUDA® (Pembrolizumab) in ColoRectal Cancer (CRC) | Experimental | Drug: TU2218 + KEYTRUDA® (Pembrolizumab)TU2218 + KEYTRUDA® (Pembrolizumab) administered, orally BID, for 2 weeks followed by 1 week of rest in 3-week cycles for TU2218 and intravenous 200mg once every 3 weeks for KEYTRUDA® (Pembrolizumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Male and females ≥18 years of age
- Life expectancy ≥12 weeks as judged by the Investigator
- Measurable disease as defined by RECIST v1.1
- ECOG 0 or 1
- Able to swallow capsules
Key exclusion criteria (41 listed)
- Myocardial infarction within 6 months prior to screening, or pericardial effusion
- History of cardiac or aortic surgery within 12 months
- 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 judgement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TU2218 + KEYTRUDA® (Pembrolizumab)TU2218: Orally administered KEYTRUDA® (Pembrolizumab): Intravenously administered | Drug | Phase 1b: TU2218 + KEYTRUDA® (Pembrolizumab) in solid tumor, Phase 2a: TU2218 + KEYTRUDA® (Pembrolizumab) in Biliary Tract Cancer (BTC), Phase 2a: TU2218 + KEYTRUDA® (Pembrolizumab) in ColoRectal Cancer (CRC), Phase 2a: TU2218 + KEYTRUDA® (Pembrolizumab) in Head and Neck Squamous Cell Carcinoma (HNSCC) |
Primary outcome
Phase 1b: To determine the Recommended Phase 2 Dose of the Combination (RP2DC) of TU2218 given with Pembrolizumab in selected advanced solid tumors
Time frame: During 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 tumors
Time frame: 24 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.
7 secondary outcomes
Phase 1b and 2a: To further evaluate the safety and tolerability of TU2218 administered in combination with pembrolizumab.
Time frame: approximately 13 months
Phase 1b and 2a: The PK of TU2218 administered in combination with pembrolizumab
Time frame: Cycle 1 (each cycle is 21 days)
Time to Progression (TTP)
Time frame: over 24 weeks
Duration of Response (DoR)
Time frame: over 24 weeks
Disease Control Rate (DCR)
Time frame: over 24 weeks
Clinical Benefit Rate (CBR)
Time frame: over 24 weeks
Overall Survival (OS)
Time frame: OS rate at 6 months = up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No. We will make our final decision after EOP2 meeting.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
TU2218 study director
TiumBio Co., Ltd.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TU2218 + KEYTRUDA® (Pembrolizumab) in people with Solid Tumor and Biliary Tract Cancer, run by TiumBio Co., Ltd. at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TiumBio Global http://www.tiumbio.com/en/ (82-31-600-1500, nce401_tu2218@tiumbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b: To determine the Recommended Phase 2 Dose of the Combination (RP2DC) of TU2218 given with Pembrolizumab in selected advanced solid tumors (time frame: During the first 21-day period (Cycle 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.