Advanced CancerPhase 1NCT04864418
AST-021p Study in Advanced Solid Tumors
A Phase 1 study testing AST-021p in people with Advanced Cancer, run by Aston Sci. Inc. at 3 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- AST-021p
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 9 Jun 2021to 5 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Seoul ST. Mary's Hospital
Seoul
About this study
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
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
Read the 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)).
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.
- Conditions
- Advanced Cancer
- Being tested
- AST-021p
- Keywords
- cancer vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST-021pDrug
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: AST-021p |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6weeks and 20weeks after AST-021p administration in each cohort group
Secondary outcomes (4)
Immunogenicity assessment
AST-021p specific IFN-γ ELISpot(Interferon Gamma Enzyme-linked immunospot) test results and ASP-021p4 \& ASP-021p5 specific IFN-γ ELISpot
Measured: 8weeks after ASP-021p administration and 20weeks after ASP-021p administration
Tumor response assessment
Disease control rate (%), objective response rate(%) and duration of response (days \& weeks)
Measured: Overall study period approximately up to 5months
Progression-Free Survival rate
PFS rate (%) at 20weeks from first IP administration
Measured: Overall study period approximately up to 5months
Overall Survival rate
OS rate (%) at 20weeks from first IP administration
Measured: Overall study period approximately up to 5months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start9 Jun 2021
- Primary completion2 Nov 2023
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aston Sci. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyong Hwa Park, MD. PhD, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864418
- Sponsor's protocol ID
- PN-021-11
- Status last verified
- Jul 2026
- First submitted
- 22 Apr 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04864418
- Acronym / sponsor ID
- PN-021-11
- Conditions
- Advanced Cancer
- Keywords
- cancer vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Aston Sci. Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort group of AST-021p for dose-escalation | Experimental | Drug: AST-021p4 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AST-021p3 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 | Drug | Cohort group of AST-021p for dose-escalation |
Primary outcome
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
4 secondary outcomes
Immunogenicity assessment
Time frame: 8weeks after ASP-021p administration and 20weeks after ASP-021p administration
Tumor response assessment
Time frame: Overall study period approximately up to 5months
Progression-Free Survival rate
Time frame: Overall study period approximately up to 5months
Overall Survival rate
Time frame: Overall study period approximately up to 5months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyong Hwa Park, MD. PhD principal investigator
Korea University Anam Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AST-021p in people with Advanced Cancer, run by Aston Sci. Inc. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.