AST-021p Study in Advanced Solid Tumors

NCT ID: NCT04864418

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-09
• Study Completion Date: 2023-11-30

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 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).

Conditions

Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort group of AST-021p for dose-escalation

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

Group Type: EXPERIMENTAL

AST-021p

Intervention Type: DRUG

3 priming immunization (2weeks x3) in 4 cohort groups (1.2mg, 2.4mg, 3.6mg and 4.8mg AST-021p) if possible, 3 boosting immunization (4weeks x 3) in cohort groups after priming immunization

Interventions

AST-021p

3 priming immunization (2weeks x3) in 4 cohort groups (1.2mg, 2.4mg, 3.6mg and 4.8mg AST-021p) if possible, 3 boosting immunization (4weeks x 3) in cohort groups after priming immunization

Intervention Type: DRUG

Eligibility 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 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aston Sci. Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyong Hwa Park, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

Korea University Anam Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Seoul ST. Mary's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

PN-021-11

Identifier Type: -

Identifier Source: org_study_id