AST-021p Study in Advanced Solid Tumors

Aston Sci.

Status and phase: Active, not recruiting; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: AST-021p

Study type: Interventional

Funder types: Industry

Identifiers

NCT04864418

PN-021-11

Details and patient eligibility

About

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

Full 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).

Enrollment: 19 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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 3 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Cohort group of AST-021p for dose-escalation

Experimental group

Description:

4 cohort groups for AST- 021p administration: Group 1) 1.2mg AST-021p, Montanide ISA 51 VG and rhuGM-CSF Group 2) 2.4mg AST-021p, Montanide ISA 51 VG and rhuGM-CSF Group 3) 3.6mg AST-021p, Montanide ISA 51 VG and rhuGM-CSF Group 4) 4.8mg AST- 021p, Montanide ISA 51 VG and rhuGM-CSF

Treatment:

Drug: AST-021p