NCT03812874

A Study of PTX-9908 Injection for Non-resectable HCC with TACE

Phase I/II Study of PTX-9908 Injection As an Inhibitor of Cancer Progression in Patients with Non-resectable Hepatocellular Carcinoma Following Transarterial Chemoembolization Treatment

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: TCM Biotech International Corp. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	PTX-9908 Injection	Proposed dose cohorts:1 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg, and 16 mg/kg. Frequency: Phase I: one dose per day for 4 consecutive weeks (20 doses). Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses). Duration: 4 weeks (Phase I) and 12 weeks (Phase II).
DRUG	Placebo	water for injection Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses). Duration: 12 weeks (Phase II)

Timeline

• Start date: 2020-10-06
• Primary completion: 2026-08-30
• Completion: 2026-12-30
• First posted: 2019-01-23
• Last updated: 2024-11-21

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study