A Study of PTX-9908 Injection for Non-resectable HCC with TACE
ConditionCarcinoma, Hepatocellular
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorTCM Biotech International Corp.
About this trial
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.
Eligibility criteria
Qualifiers
Unresectable hepatocellular carcinoma and at intermediate-stage HCC (BCLC stage B or Child-Pugh class A/B with large or multifocal HCC, no vascular invasion, or extrahepatic spread) with completed TACE procedure in 4 weeks before day 1 of study intervention infusion.
Recovered from TACE treatment and procedure related toxicities including ALT/AST and bilirubin within normal limit or reference numeric value (reference value is defined as the test value before TACE procedure).
ECOG (Eastern Cooperative Oncology Group) performance status < 2.
Absolute neutrophil count > 1,200/µL
Disqualifiers
1. Patient with Child-Pugh B8-9.
Patient who has had anti-cancer therapy including surgery, radiotherapy, immunotherapy, or chemotherapy (except in TACE regimen) within 4 weeks prior to the screening visit.
Patient who has received any other investigational agents within 4 weeks prior to the screening visit.
Patient who has not recovered from the side effects of the earlier investigational agent or had anti-cancer therapy including surgery, radiotherapy, immunotherapy, or chemotherapy.
Trial design
Treatments tested in this trial
- PTX-9908 Injection
- Placebo
Treatment groups
50 Participants
are divided into 2 treatment groupsLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
National Taiwan University HospitalRecruiting10002, New Taipei City, Taiwan
Taiwan
TaiwanSponsors and collaborators
Source ClinicalTrials.gov