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Treatment of MB07133 Plus Sintilimab in Patients With Hepatocellular Carcinoma

NCT06141109 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-11-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The First Hospital of Jilin University

    collaborator OTHER

  • Xi'an Xintong Pharmaceutical Research Co.,Ltd.

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-18
Primary Completion
2024-07-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06141109 on ClinicalTrials.gov