Phase 1/2 Study of TU2218 for Advanced Solid Tumors
This study is testing a new oral medication called TU2218, both by itself and in combination with an anti-PD-1 antibody (a type of immunotherapy given through an IV), for people with advanced solid tumors. The main goals are to find the safest and most effective dose of TU2218 (Phase 1) and then see how well it shrinks tumors (Phase 2). You may be able to join if you are at least 18 years old, have a life expectancy of at least 12 weeks, and your tumor can be measured. The study plans to enroll 240 participants, but its current status is unclear.
- Study design
- This is an interventional study with two parts: Part A tests TU2218 alone, and Part B tests TU2218 with an anti-PD-1 antibody. It aims to enroll 240 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures how well the treatment works for 24 weeks in Phase 2. The duration of follow-up after treatment is not specified.
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NCT05204862
Phase 1/2 Study of TU2218 Alone and in Combination With Checkpoint Inhibitors in Patients With Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentTiumBio Co., Ltd.
~240 participants
Updated 2023-04-03 on ClinicalTrials.gov
What's tested:TU2218Anti-PD-1 antibody
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Maximum Tolerated Dose (MTD) of TU2218 administered alone (Part A) and in combination with anti-PD-1 antibody (Part B)
Measured over From the beginning of Cycle 1 through Cycle 2 (each cycle is 21 days)
+1 more outcome measured
Conditions
NCT05204862
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Asan Medical Center
Seoul, South Koreano site contact published
Recruiting
NEXT Oncology
San Antonio, Texasno site contact published
Recruiting
Seoul National University Hospital
Seoul, South Koreano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- TU2218 · STUDY_DIRECTOR · TiumBio Co., Ltd.
Who to contact
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Eligibility criteria
Inclusion
Males and females at least 18 years of age at the time of consent (ie, screening), or according to local regulatory requirement if the legal age for consenting for study participation is more than 18 years.
Life expectancy ≥12 weeks as judged by the Investigator.
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; except for Phase1a that can enroll patients with either measurable and/or non-measurable disease.
Eastern Cooperative Oncology Group (ECOG) 0 or 1.
Able to swallow capsules.
Histologically or cytologically documented advanced solid tumor for which no effective standard therapy exists, or standard therapy has failed (Phase 1a).
Histologically or cytologically documented advanced solid tumor for which no effective standard therapy exists, and for which standard therapy containing an anti-PD-(L)1 agent has failed after an initial response or stabilization of at least 4-month duration (Phase 1b and 2a).
Adequate hematological function, coagulation defined by:
Adequate hepatic and renal functions defined by:
Able to understand and to comply with all protocol requirements, instructions, and restrictions.
QT interval corrected using Fridericia's formula (QTcF) interval ≤460 msec on screening ECG.
Normal ejection fraction (within the reference range of the institution).
A washout period of 4 weeks for any biologic material and a minimum of 5 half-lives for any chemotherapy is required prior to the start of treatment with resolution of any toxicity to maximum Grade 1 (except alopecia)
Completion of radiotherapy at least 14 days prior to the start of treatment with resolution of any toxicity to maximum Grade 1
Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of study treatment. For the purpose of this study, female patients of childbearing potential are 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)
Exclusion
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.
Received prior treatment targeting the signaling pathway of TGF-β.
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, antiplatelet agents, or factor Xa inhibitors throughout the study and for at least 28 days after the last administration of study treatment.
Regular use of aspirin (\>325mg/day) or other non-steroidal anti-inflammatory drugs with antiplatelet activity or treatment with dipyramidole, ticlopidine, clopidogrel, or cilostazol within 10 days of first administration 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.
Active infection requiring systemic antibiotic therapy.
Receipt of any live vaccine or live-attenuated vaccine within 30 days prior to the first drug administration and while participating the study.
Unable to unwilling to stop use of strong inhibitors of CYP1A2, CYP2C8, and CYP3A4, and strong inhibitors of P-gp and BCRP at least 8 days prior to study entry (Day 1) or within all dose escalation cohorts.
Unable or unwilling to stop use of gastric pH elevating agents including proton pump inhibitors, H2-recpetor antagonists and antacide at least 8 days prior to study entry (Day 1) or within all dose escalation cohorts.
Unwilling to stop use of herbal supplements or traditional herbal medicines.
Known substance abuse concurrent treatment with non-permitted drugs.
Known history, or suspected hypersensitivity to any excipients of the clinical study drugs.
Undergone major surgeries within 28 days of first dosing, or have a planned surgery during the study period.
Female patients who are breastfeeding.
Female patients must not be pregnant or at risk to become pregnant during the study. Fertile male and female patients must agree to use an effective barrier method of birth control to avoid pregnancy (for female patients a double-barrier method of contraception, for male patients a condom with spermicide) or total abstinence from the time of providing informed consent until 30 days after the last administration of TU2218.
Any other serious medical condition which in the Investigator's opinion would preclude safe participation in the study.
Unable to stop chronic systemic steroid therapy or any other immunosuppressive mediacation
Use of oral, inhaled, or topical corticosteroid, at doses \> 10mg/day prednisolone or equivalent and the dose must be stable over 4 weeks prior to Day1 of Cycle1.
Active autoimmune disease or history of autoimmune disease, except vitiligo, hypothyroidism, or resolved childhood asthma/atropy
Known tolerance to an anti-PD(L)1 agent during prior exposure
What this trial measures
- Phase 1: Maximum Tolerated Dose (MTD) of TU2218 administered alone (Part A) and in combination with anti-PD-1 antibody (Part B)From the beginning of Cycle 1 through Cycle 2 (each cycle is 21 days)
The MTD is determined as DLTs.
- Phase 2: Overall Response rate (ORR) of TU2218 administered alone (Part A) and in combination with anti-PD-1 antibody (Part B)24 weeks
ORR is defined as the proportion of patients who have a PR and CR.