AST-021p Study in Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
Description
Recurrent or advanced solid cancer patients without applicable standard treatments will be included in the 4 dose groups (4 cohort groups- 1.2mg, 2.4mg,3.6mg and 4.8mg) of AST-021p. Participants in each cohort group will be treated 3 times in each dose (3 priming immunications) This study will apply...
Recurrent or advanced solid cancer patients without applicable standard treatments will be included in the 4 dose groups (4 cohort groups- 1.2mg, 2.4mg,3.6mg and 4.8mg) of AST-021p. Participants in each cohort group will be treated 3 times in each dose (3 priming immunications) This study will apply a modified 3+3 design for dose-escalation. 1 participant will be registered in the lowest dose cohort group(1.2mg) and when the safety and tolerance of the AST-021p(1.2mg) are identified in the the first group, dose will be increased sequentially and accordingly, the safety and tolerance will be assessed for six participants in the other cohort groups (group2(2.4mg), group3(3.6mg) and group4(4.8mg)). Participants receiving priming immunization only will be assessed up to End of Treatment(EOT) and participants who recive boosting immunization will be evaluated until the end of study(EOS).
Tracking Information
- NCT #
- NCT04864418
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Kyong Hwa Park, MD. PhD Korea University Anam Hospital
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