Actively Recruiting
Phase 1/2 Study of TU2218 Alone and in Combination With Checkpoint Inhibitors in Patients With Advanced Solid Tumors
Led by TiumBio Co., Ltd. · Updated on 2023-04-03
240
Participants Needed
3
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1/2 Study of TU2218 Alone and in Combination With Checkpoint Inhibitors in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Life expectancy of at least 12 weeks
- Measurable disease by RECIST 1.1 (except Phase 1a allowing non-measurable disease)
- ECOG performance status 0 or 1
- Able to swallow capsules
- Advanced solid tumor with no effective standard therapy or failed standard therapy (Phase 1a)
- Advanced solid tumor with failed anti-PD-(L)1 standard therapy after initial response or stabilization of at least 4 months (Phase 1b and 2a)
- Adequate blood counts: neutrophils 61500 cells/bcL, platelets 65100,000/bcL, hemoglobin 659.0 g/dL, INR <1.5 x ULN
- Adequate liver and kidney function: bilirubin 651.5 x ULN, AST and ALT 653 x ULN (up to 5 x ULN if liver metastases), creatinine clearance >60 mL/min
- QTcF interval 6460 msec on ECG
- Normal heart ejection fraction
- Washout period of 4 weeks for biologics and minimum 5 half-lives for chemotherapy with resolved toxicity to Grade 1 or less
- Completed radiotherapy at least 14 days prior with resolved toxicity to Grade 1 or less
- Female patients of childbearing potential must have a negative pregnancy test within 7 days before treatment
- Able to understand and comply with study requirements
You will not qualify if you...
- Myocardial infarction or pericardial effusion within 6 months
- Cardiac or aortic surgery within 6 months
- Unstable angina, stroke, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or arterial occlusive disease in past 12 months
- Severe congestive heart failure (NYHA class III/IV)
- Major arrhythmia or ECG abnormalities judged by investigator
- Uncontrolled high blood pressure during screening
- Grade 3 elevated troponin 1 or persistent elevated brain natriuretic peptide
- Active or significant infections including active hepatitis B, C, HIV, or AIDS (inactive hepatitis B carriers allowed)
- History of interstitial pneumonitis
- Uncontrolled brain or central nervous system metastases or large uncontrolled effusions
- Difficulty swallowing or malabsorption conditions
- Prior treatment targeting TGF-9 pathway
- Tumor compressing major blood vessels or tumor likely to bleed
- History of severe bleeding or inability to stop anticoagulation
- Regular use of high-dose aspirin or antiplatelet drugs within 10 days before treatment
- Moderate or severe heart valve defects
- History of aneurysms
- Active infection needing systemic antibiotics
- Live vaccine use within 30 days prior
- Unable or unwilling to stop strong CYP and P-gp/BCRP inhibitors or gastric pH elevating agents before study
- Unwilling to stop herbal supplements
- Substance abuse or use of prohibited drugs
- Known hypersensitivity to study drugs
- Major surgery within 28 days or planned during study
- Breastfeeding females
- Pregnancy or risk of pregnancy without effective contraception
- Serious medical condition precluding safe participation
- For combination therapy: unable to stop chronic steroid or immunosuppressive therapy
- Use of corticosteroids >10 mg/day prednisolone or equivalent
- Active or history of autoimmune disease except specified exceptions
- Prior tolerance to anti-PD-(L)1 agents
AI-Screening
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Trial Site Locations
Total: 3 locations
1
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
2
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
3
Asan Medical Center
Seoul, South Korea, 05505
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
5
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