A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hepatocellular Carcinoma
- Intrahepatic Cholangiocarcinoma
- Liver Metastases
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Intrapatient dose escalations continuing into interpatient dose escalations to end with dose expansion cohorts.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study will be conducted in three phases. The initial phase, 1a, will enroll up to 12 subjects and include a total of one dose escalation per patient. All patients will receive an initial probe dose before entering the actual treatment cycles. Once pre-defined criteria for starting phase 1b has ...
This study will be conducted in three phases. The initial phase, 1a, will enroll up to 12 subjects and include a total of one dose escalation per patient. All patients will receive an initial probe dose before entering the actual treatment cycles. Once pre-defined criteria for starting phase 1b has been met among the enrolled patients in phase 1a, the next phase of the study will be initiated. Phase 1b will enroll up to 30 patients in a 3+3 design with interpatient dose escalations. All dose escalation decisions will be made by an independent safety review committee that will meet regularly during the study conduct. As the MTD has been met, the SRC will provide a RP2D which will initiate phase 2a of the study. In phase 2a only HCC and iCCA patients will be recruited into two expansion cohorts.
Tracking Information
- NCT #
- NCT03781934
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ruth Plummer, Professor Northern Institute for Cancer Research, Newcastle
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