Actively Recruiting
A Study of PTX-9908 Injection for Non-resectable HCC with TACE
Led by TCM Biotech International Corp. · Updated on 2024-11-21
50
Participants Needed
1
Research Sites
325 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, Phase I/II study in patients with non-resectable hepatocellular carcinoma following TACE treatment. Phase I (Open-label dose escalation) This study will be an open-label study with an Accelerated Phase and a Standard Phase. For the Accelerated Phase of the study, one patient per dose level (1 mg/kg, and 2 mg/kg) is planned. For the dose levels in the standard phase (4 mg/kg, 8 mg/kg and 16 mg/kg), it will follow the Fibonacci's rule of 3 + 3 design. All eligible patients who have received TACE treatment and recovered well, will be administrated PTX-9908 Injection intravenously one dose per day for 5 days on Week 1 (excludes weekends and public holidays), and one dose per week (on Day 8, Day 15, and Day 22) for 3 consecutive weeks. The 4-week treatment period, will be followed by a 2-week follow-up period. Phase II (Randomized placebo controlled dose expansion) The objective of phase II is to further evaluate the safety, tolerability and antitumor activity of PTX-9908 Injection for patients with non-resectable hepatocellular carcinoma following TACE treatment. Approximately 24 eligible patients who have received TACE treatment and recovered, will be randomized to PTX-9908 Injection using the predetermined dose in phase I or the vehicle placebo in a 2:1 ratio. PTX-9908 Injection or placebo will be administered intravenously one dose per day for 5 days in Week 1 (excludes weekends and public holidays), and one dose per week till Week 12 (Day 78). The 12-week treatment period, will be followed by a 2-week follow-up period.
CONDITIONS
Official Title
A Study of PTX-9908 Injection for Non-resectable HCC with TACE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with unresectable hepatocellular carcinoma at intermediate stage (BCLC stage B or Child-Pugh class A/B) with large or multifocal tumors, no vascular invasion, or extrahepatic spread
- Completed transarterial chemoembolization (TACE) procedure within 4 weeks before starting study treatment
- Recovered from TACE-related toxicities; liver enzymes and bilirubin are within normal limits or baseline values
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2
- Adequate organ and marrow function: neutrophils > 1,200/µL, hemoglobin > 9 g/dL, platelets > 100,000/µL, total bilirubin less than 2 times the upper limit of normal
- Adequate kidney function with estimated glomerular filtration rate (eGFR) over 60 mL/min/1.73 m2
- Negative pregnancy test for females with childbearing potential
- Agree to use effective contraception during the study and for 4 weeks after completion (applies to females with childbearing potential and males with partners who have childbearing potential)
- At least 20 years old
- Expected to live at least 6 months at screening
- Able to understand and sign informed consent
You will not qualify if you...
- Child-Pugh classification B8-9
- Received anti-cancer therapy (surgery, radiotherapy, immunotherapy, chemotherapy except TACE) within 4 weeks before screening
- Received other investigational agents within 4 weeks before screening
- Not recovered from side effects of prior cancer treatments
- Known brain, leptomeningeal, or epidural metastases unless treated and controlled for 3 months or more
- History of other cancers except treated carcinoma in situ of cervix, ductal carcinoma in situ of breast, or basal/squamous cell skin cancer
- History of heart attack, uncontrolled heart problems, unstable arrhythmias, or symptomatic peripheral arterial disease
- History of HIV infection
- Active, uncontrolled infections requiring systemic treatment
- Poor liver function indicated by serum bilirubin greater than 2 mg/dL, Child-Pugh Class C, severe coagulopathy, or active hepatic encephalopathy
- Known allergy to biological agents or polypeptides similar to PTX-9908 Injection
- Pregnant or nursing women
- Other medical conditions posing unacceptable risk or interfering with study conduct
- Unwilling or unable to comply with study protocol
- Marked prolongation of QT/QTc interval greater than 480 milliseconds
- Additional risk factors for torsades de pointes such as heart failure, low potassium, or family history of Long QT Syndrome
- Use of medications that prolong QT/QTc interval
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
New Taipei City, Taiwan, Taiwan, 10002
Actively Recruiting
Research Team
C
Chien-Hung Chen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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