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NCT Number: NCT04864418

AST-021p Study in Advanced Solid Tumors

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

Completed

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Key information

Conditions

Advanced Cancer

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Anam Hospital, Seoul, South Korea

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About this study

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)).

For subjects who received only priming immunization, safety and immunogenicity are assessed at the End of Treatment (EOT) visit. For subjects who received boosting immunization, safety and immunogenicity are assessed at the first booster dose (V6) and the End of Study (EOS) visit respectively.

Survival follow-up will be conducted every 3 months until the EOS visit of the last subject in the 4.8mg dose group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 6weeks and 20weeks 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 outcomes

  1. Immunogenicity assessment

    Time frame: 8weeks after ASP-021p administration and 20weeks after ASP-021p administration

    AST-021p specific IFN-γ ELISpot(Interferon Gamma Enzyme-linked immunospot) test results and ASP-021p4 & ASP-021p5 specific IFN-γ ELISpot

  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 20weeks from first IP administration

  4. Overall Survival rate

    Time frame: Overall study period approximately up to 5months

    OS rate (%) at 20weeks from first IP administration

Sponsors and collaborators

Lead sponsor

Aston Sci. Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Apr 28, 2021
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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