Status:
UNKNOWN
AST-021p Study in Advanced Solid Tumors
Lead Sponsor:
Aston Sci. Inc.
Conditions:
Advanced Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief 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
Detailed 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 ea...
Eligibility Criteria
Inclusion
- has recurrent or metastatic solid cancer that has been proven histologically or cytologically and cannot be treated with surgery or radiotherapy for the purpos of complete remission
- does not have a standard treatment that can be applied clinically according to the investigator's judgment
- has an expected life expectancy of more than 3 months
- adults aged 19 or older based on screening day
- ECOG performance status : 0\~1
Exclusion
- Has a history of hypersensitivity or other contraindications to rhGM-CSF and Montanide ISA 51 VG
- Has a history of other primary malignant tumor
- Has autoimmune diseases or inflammatory diseases
- Has a history of active primary immunodeficiency disease
- Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
- Is pregnant or breastfeeding or expecting to conceive children
- has a history of immune suppression therapy ≤4 weeks prior to the screening day
Key Trial Info
Start Date :
June 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04864418
Start Date
June 9 2021
End Date
November 1 2023
Last Update
July 20 2023
Active Locations (3)
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1
Korea University Anam Hospital
Seoul, South Korea
2
Korea University Guro Hospital
Seoul, South Korea
3
Seoul ST. Mary's Hospital
Seoul, South Korea