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AST-021p Study in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04864418
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : June 23, 2021
Sponsor:
Information provided by (Responsible Party):
Aston Sci. Co., Ltd.

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


Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: AST-021p Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 9, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : February 2023

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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)

  2. Tumor response assessment [ Time Frame: Overall study period approximately up to 5months ]
    Disease control rate (%), objective response rate(%) and duration of response (days & weeks)

  3. Progression-Free Survival rate [ Time Frame: Overall study period approximately up to 5months ]
    PFS rate (%) at End of Study

  4. Overall Survival rate [ Time Frame: Overall study period approximately up to 5months ]
    OS rate (%) at End of study



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864418


Contacts
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Contact: Hyunwon Shin, MD. PhD +82-2-2038-2347 hyunwon.shin@astonsci.com
Contact: Aston Science astonsci@astonsci.com

Locations
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Korea, Republic of
Korea University Guro Hospital Not yet recruiting
Seoul, Guro-gu, Korea, Republic of
Contact: Eun-joo Kang, MD         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Contact: Kyong Hwa Park, MD, PhD         
Sponsors and Collaborators
Aston Sci. Co., Ltd.
Investigators
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Principal Investigator: Kyong Hwa Park, MD. PhD Korea University Anam Hospital
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Responsible Party: Aston Sci. Co., Ltd.
ClinicalTrials.gov Identifier: NCT04864418    
Other Study ID Numbers: PN-021-11
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Aston Sci. Co., Ltd.:
cancer vaccine