AST-021p Study in Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aston Sci. Co., Ltd.

Criteria

Inclusion Criteria:

• 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 6 months

• adults aged 19 or older based on screening day

• ECOG performance status : 0~1

Exclusion Criteria:

• 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