A Study to Evaluate Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 Combined With Anti-PD-1 Antibody
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Solid Tumor
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
subjects will be treated with HBM4003 in combination with pembrolizumab for up to 2 years or until confirmed disease progression, unacceptable tolerability or treatment discontinuation through withdrawal of consent occurs, whichever happens first. This trial consists of : A screening period: 28 days...
subjects will be treated with HBM4003 in combination with pembrolizumab for up to 2 years or until confirmed disease progression, unacceptable tolerability or treatment discontinuation through withdrawal of consent occurs, whichever happens first. This trial consists of : A screening period: 28 days A treatment period: Part 1a dose confirmation study Part 1b dose expansion study A post-treatment follow-up period, including A safety follow-up period: 28 days after the last dose of study drug; Post-treatment follow-up visit: day 84 after the last dose of study drug; Survival follow-up.
Tracking Information
- NCT #
- NCT04866485
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Shun LU, Doctor Shanghai Chest Hospital
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