AST-021p Study in Advanced Solid Tumors

NCT04864418 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: PN-021-11
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

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

Conditions

Advanced Cancer

Keywords

cancer vaccine

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by AST-021p

  After AST-021p administration in patients with advance solid tumor, safety and tolerance are assessed for each dose group(1.2mg,2.4mg, 3.6mg \&4.8mg) Safety and tolerance evaluation variables : 1)adverse events 2) Vital signs 3)Physical examination 4) ECOG performance evaluation 5)ECG examination 6)Laboratory examination

  6weeks after AST-021p administration in each cohort group

Secondary Outcomes (4)

• Immunogenicity assessment

  8weeks after ASP-021p administration (Priming immunization case) or 20weeks after ASP-021p(Priming immunization and Boosting immunization case)

• Tumor response assessment

  Overall study period approximately up to 5months

• Progression-Free Survival rate

  Overall study period approximately up to 5months

• Overall Survival rate

  Overall study period approximately up to 5months

Study Arms (1)

Cohort group of AST-021p for dose-escalation

EXPERIMENTAL

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

Drug: AST-021p

Interventions

AST-021p 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

Cohort group of AST-021p for dose-escalation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aston Sci. Inc.: lead

Study Sites (3)

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Seoul ST. Mary's Hospital

Seoul, South Korea

Location

Study Officials

• Kyong Hwa Park, MD. PhD

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 28, 2021
• Study Start: June 9, 2021
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)