NCT06141096

MB07133 for the Treatment of Patients With Unresectable Hepatocellular Carcinoma

A Multi-center, Open-label, Randomized Phase II Clinical Study to Evaluate the Efficacy and Safety of I.V.Infusion of MB07133 in Patients With Unresectable HCC

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (estimated)
• Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A randomized, open, multicenter clinical trial design was adopted, planned to be conducted in three stages, with 91 participants expected to be included in the study to evaluate the efficacy, tolerance, and safety of different doses of MB07133 in the treatment of unresectable advanced primary liver cancer.

Detailed description

first stage：The investigators plan to recruit 20 cases for mid dose group exploration: the injection MB07133600mg/m2/day group and the 1200mg/m2/day group, with 10 cases recruited for each group. The treatment cycle is 28 days, with each dose group receiving 7 days of medication and 21 days of rest per cycle. second stage：Based on the data results of the first stage, the 1200mg/m2/day dose group MB07133 was selected for further expansion, with the same administration method as the first stage. Plan to recruit 30 subjects. third stage：Based on the treatment results of H201110LC3, the 1800mg/m2/day dose group was selected for further expansion, and 40 subjects were recruited with the same administration method as the first stage.

Conditions

• Safety Issues
• Effect of Drug
• Tolerance

Interventions

Type	Name	Description
DRUG	MB07133	Evaluate the effectiveness and safety of different doses of MB07133

Timeline

• Start date: 2020-01-17
• Primary completion: 2024-06-30
• Completion: 2025-12-31
• First posted: 2023-11-21
• Last updated: 2023-11-21

Locations

1 site across 1 country: China