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AST-021p Study in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04864418
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : June 23, 2021
Information provided by (Responsible Party):
Aston Sci. Co., Ltd.

Tracking Information
First Submitted Date  ICMJE April 22, 2021
First Posted Date  ICMJE April 28, 2021
Last Update Posted Date June 23, 2021
Actual Study Start Date  ICMJE June 9, 2021
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2021)
Number of participants with treatment-related adverse events as assessed by AST-021p [ Time Frame: 6weeks after AST-021p administration in each cohort group ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2021)
  • Immunogenicity assessment [ Time Frame: 8weeks after ASP-021p administration (Priming immunization case) or 20weeks after ASP-021p(Priming immunization and Boosting immunization case) ]
    ASP-021p specific IFN-γ ELISpot(Interferon Gamma Enzyme-linked immunospot) test results and ASP-021p4 & ASP-021p5 specific IFN-γ ELISpot ( spots/250,000 Tcell of pre ASP-021p and post ASP-021p)
  • Tumor response assessment [ Time Frame: Overall study period approximately up to 5months ]
    Disease control rate (%), objective response rate(%) and duration of response (days & weeks)
  • Progression-Free Survival rate [ Time Frame: Overall study period approximately up to 5months ]
    PFS rate (%) at End of Study
  • Overall Survival rate [ Time Frame: Overall study period approximately up to 5months ]
    OS rate (%) at End of study
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE AST-021p Study in Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Study to Evaluate the Safety, Tolerability and Optimal Immunogenic Dose of Therapeutic Cancer Vaccine (AST-021p) in Patients With Advanced Solid Tumors
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE Drug: 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
Study Arms  ICMJE Experimental: 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

Intervention: Drug: AST-021p
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2021)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hyunwon Shin, MD. PhD +82-2-2038-2347
Contact: Aston Science
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04864418
Other Study ID Numbers  ICMJE PN-021-11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aston Sci. Co., Ltd.
Study Sponsor  ICMJE Aston Sci. Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyong Hwa Park, MD. PhD Korea University Anam Hospital
PRS Account Aston Sci. Co., Ltd.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP