Actively Recruiting
Phase I/II Study of PTX-9908 Injection as an Inhibitor of Cancer Progression in Non-resectable Hepatocellular Carcinoma Following Transarterial Chemoembolization
Led by TCM Biotech International Corp. · Updated on 2024-11-21
50
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating PTX-9908 Injection in a Phase I/II clinical study involving patients with non-resectable hepatocellular carcinoma (HCC) who have undergone transarterial chemoembolization (TACE) treatment. The study aims to assess the safety, tolerability, and antitumor activity of PTX-9908 Injection in this patient population. The trial includes an open-label dose escalation phase followed by a randomized placebo-controlled dose expansion phase to better understand the treatment's effects. In Phase I, the study uses an open-label design with escalating doses of PTX-9908 Injection given intravenously at several dose levels. Patients receive one dose per day for five days in the first week (excluding weekends and holidays), then one dose weekly for three more weeks, completing a four-week treatment period followed by two weeks of follow-up. Phase II randomizes approximately 24 patients to receive either PTX-9908 Injection or a placebo in a 2:1 ratio, with dosing schedules extending to 12 weeks and a two-week follow-up period. Participants will undergo regular assessments including monitoring of adverse events, dose limiting toxicities, tumor response, and blood tests at scheduled timepoints throughout treatment and follow-up periods. Safety is evaluated weekly in Phase I and through week 16 in Phase II. Additional measures include pharmacokinetics, tumor response evaluations, and biomarkers such as AFP levels. The total study duration varies per phase but includes intensive monitoring to assess treatment effects and patient safety.
CONDITIONS
Brief Title
A Study of PTX-9908 Injection for Non-resectable HCC with TACE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of unresectable hepatocellular carcinoma at intermediate stage (BCLC stage B or Child-Pugh class A/B) with no vascular invasion or extrahepatic spread
- Completed transarterial chemoembolization (TACE) procedure within 4 weeks before study treatment
- Recovered from TACE-related toxicities with liver enzymes and bilirubin 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 <2 times upper limit of normal)
- Adequate kidney function with estimated glomerular filtration rate (eGFR) greater than 60 mL/min/1.73m2
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception during and for at least 4 weeks after study participation for females and male partners
- Age 20 years or older
- Anticipated life expectancy of at least 6 months
- Ability to understand and sign informed consent
You will not qualify if you...
- Child-Pugh score B8-9 or worse liver function
- Anti-cancer therapies other than TACE within 4 weeks before screening
- Prior investigational agents within 4 weeks before screening
- Unrecovered side effects from previous anti-cancer therapies
- Known brain or central nervous system metastases unless controlled for 3 months
- History of other cancers except certain treated in situ or skin cancers
- History of myocardial infarction, uncontrolled heart conditions, or unstable arrhythmias
- Positive HIV serology
- Active, uncontrolled infections requiring systemic treatment
- Poor liver function indicated by high bilirubin, severe coagulopathy, or hepatic encephalopathy
- Known allergy to biological agents or similar polypeptides
- Pregnant or nursing women
- Medical conditions posing unacceptable risk or interfering with study participation
- Inability or unwillingness to comply with study protocol
- Marked prolongation of QT/QTc interval or risk factors for torsades de pointes
- Use of medications that prolong QT/QTc interval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks (Phase I) or up to 12 weeks (Phase II)
Participants receive PTX-9908 Injection or placebo by IV injection according to assigned dose cohorts and schedules.
Daily visits for up to 4 weeks (Phase I) or daily and weekly visits for up to 12 weeks (Phase II)
Duration - Up to 4 weeks after treatment
Participants are monitored for safety and treatment effects after completing the treatment phase.
Periodic visits during follow-up period
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
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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