NCT06141109

Treatment of MB07133 Plus Sintilimab in Patients With Hepatocellular Carcinoma

Safety, Tolerability and Efficacy of MB07133 Plus Sintilimab in Patients With Hepatocellular Carcinoma，a Phase 1/2a Study

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

An open-label, multi-dose clinical trial design was used to investigate the combination of MB07133 injection combined with Sintilimab in the treatment of primary liver cancer in phase I/IIa studies, including two phases of dose escalation and dose expansion，in order to evaluate the safety and efficacy of MB07133 injection combined with Sintilimab.

Conditions

• Safety Issues
• Efficacy
• MTD

Interventions

Type	Name	Description
DRUG	Sintilimab 200mg+MB07133 600mg	1. Adopting the classic "3+3" scheme design, 3 dose groups, with a cycle of 21 days. On the first day of each cycle, a single infusion of Sintilimab is given, and MB07133 is given for 7 consecutive days after a 2-hour interval between infusion initiation. 2. Sintilimab 200mg+MB07133 1800mg, recruiting 30 subjects，the administration method is as 1.

Timeline

• Start date: 2022-01-18
• Primary completion: 2024-07-31
• Completion: 2025-12-31
• First posted: 2023-11-21
• Last updated: 2023-11-21

Locations

1 site across 1 country: China