A Study of PTX-9908 Injection for Non-resectable HCC With TACE
Status:
Recruiting
Trial end date:
2021-12-30
Target enrollment:
Participant gender:
Summary
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.