A Phase I Study of AL8326 in Advanced Solid Tumor
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Solid Tumors
- 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 70 years
- Gender
- Both males and females
Description
This is a Phase 1 study to evaluate the safetyand efficacy of 28-day cycles of AL8326 therapy. The study is divided into three parts. Part I To evaluate the dose limiting toxicity (DLT) and general safety during the first 28-day cycle of Al8326 therapy and to evaluate the MTD. It will include a eval...
This is a Phase 1 study to evaluate the safetyand efficacy of 28-day cycles of AL8326 therapy. The study is divided into three parts. Part I To evaluate the dose limiting toxicity (DLT) and general safety during the first 28-day cycle of Al8326 therapy and to evaluate the MTD. It will include a evaluation of 3 subjects per cohort in a 3+3 design in. Part II Subject will receive a dose from Part 1 of this study for continuous 28-Day cycles of therapy. Part III This design adopts 3 + 3 dose de-escalation method for exploration. At the same time, the safety, tolerance and pharmacokinetics were observed.
Tracking Information
- NCT #
- NCT04890587
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nong Yang Central organization
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