AST-021p Study in Advanced Solid Tumors

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability and optimal Immunogenic dose of therapeutic cancer vaccine (AST-021p) in patients With advanced solid tumors A phase 1 study

Clinical Trial 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 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). ;

Study Design

Related Conditions & MeSH terms

Advanced Cancer

Clinical Trial Details

NCT number	NCT04864418
Study type	Interventional
Source	Aston Sci. Inc.
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	June 9, 2021
Completion date	November 2023

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