Advanced Ovarian CancerPhase 2Cornerstone4NCT05794659
Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer
A Phase 2 study testing AST-201, Paclitaxel and Carboplatin in people with Advanced Ovarian Cancer, run by Aston Sci. Inc. at 1 site in United States.
Trial summary
The purpose of this phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine AST-201 (pUMVC3-hIGFBP-2) in patients with newly diagnosed homologous-recombination proficient(HRP) advanced ovarian cancer (Stage III) after debulking surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Ovarian Cancer
- What is being tested?
- AST-201, Paclitaxel and Carboplatin
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2027to 1 Jun 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed stage III (FIGO classification) epithelial ovarian cancer including primary peritoneal cancer, fallopian-tube cancer
- Has received upfront surgery and optimally debulked(a residual tumor less than 1 cm)
- Can start adjuvant therapy within 6 weeks of debulking surgery
- Has Homologous Recombination Proficiency (HRP) tumor defined by FDA-approved testing
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Demonstrates adequate organ function.
Who cannot join
- Has a history of hypersensitivity or other contraindications to rhuGM-CSF
- Has a history of active malignancy ≤5 years prior to first administration of investigational drug except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease
- Is on immune suppression therapy or has a history of immune suppression therapy ≤4 weeks prior to the first administration of investigational drugs
- Has active or prior autoimmune disease or inflammatory disease
- Has active infectious disease including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
- Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Washington
Seattle, Washington, 98109
John B. Liao, MD, PhD
About this study
Official title: A Randomized Phase 2 Study to Evaluate the Efficacy and Safety for Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer (Cornerstone-004)
The purpose of this phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine AST-201 (pUMVC3-hIGFBP-2) in patients with newly diagnosed homologous-recombination proficient(HRP) advanced ovarian cancer (Stage III) after debulking surgery. Patients will receive AST-201 with rhuGM-CSF(Colony Stimulating Factor) or placebo with rhuGM-CSF in combination with standard adjuvant chemotherapy(Paclitaxel/Carboplatin).
Read the detailed description
The study will comprise a screening period of -28 Days prior to initiation of study treatment (Day 1); an enrollment period of 24 months; the treatment duration will be approximately of 5 months.
The study will evaluate whether the addition of AST-201/rhuGM-CSF to the standard adjuvant chemotherapy will extend the Progression Free Survival(PFS) rate. Survival follow-up will be performed every 3 months (±14 days) after the End of treatment (EOT) visit for 2 years after randomization and every 6 months (±28 days) thereafter until disease progression or death from any cause or withdrawal of consent whichever comes first. Survival follow-up visits will be conducted by telephone, in-person visit, or chart review. The end of study (EOS) is defined as 2 years after the date of last patient enrollment.
- Conditions
- Advanced Ovarian Cancer
- Being tested
- AST-201, Paclitaxel, Carboplatin, Placebo, rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)
- Keywords
- cancer vaccine, phase 2 study, Advanced ovarian cancer, homologous-recombination proficient (HRP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST-201Biological
Also called pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine
i.d. (3-week interval, 3 cycles in total)
PaclitaxelDrug
Also called Taxol
3-week interval, 6 cycles in total
CarboplatinDrug
Also called Paraplatin
3-week interval, 6 cycles in total
PlaceboDrug
Also called Normal saline (USP)
i.d. (3-week interval, 3 cycles in total)
rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)Drug
Also called sargramostim, Leukine
i.d. (3-week interval, 3 cycles in total)
| Study group | Role | What they receive |
|---|---|---|
| AST-301 | Experimental | AST-201 with rhuGM-CSF (3-week interval, 3 cycles in total)
Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total)
* Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles Receives: Biological: AST-201; Drug: Paclitaxel; Drug: Carboplatin; Drug: rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor) |
| Placebo | Placebo comparator | Placebo with rhuGM-CSF (3-week interval, 3 cycles in total)
Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total)
*Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Placebo; Drug: rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
the time from the date of randomization to disease progression, or death from any cause whichever occurs first
Measured: overall study duration (approximately 48 months)
Secondary outcomes (4)
2-year PFS rate
proportion of patients alive without disease progression or death at two years after the randomization
Measured: 24months from the first dose of AST-301 administration
Overall Survival (OS)
the time from the date of randomization to death from any cause
Measured: overall study duration (approximately 48 months)
AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot )
AST-201 specific IFN-gamma ELISpot
Measured: 17months
Number of participants with Adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0)
Adverse events (AEs) Treatment-emergent adverse events (TEAEs) Serious adverse events (SAEs) Vital signs Physical examination Eastern Cooperative Oncology Group (ECOG) performance status Electrocardiogram (ECG) test Laboratory tests
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Jun 2027 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Ovarian 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind, randomized, placebo-controlled, multicenter, phase 2 clinical study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aston Sci. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hun Jung, MD, PhD, Study director, jhun@astonsci.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794659
- Sponsor's protocol ID
- PN-201-22
- Acronym
- Cornerstone4
- Status last verified
- Oct 2026
- First submitted
- 7 Mar 2023
- Last updated
- 27 Oct 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study to Evaluate the Efficacy and Safety for Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer (Cornerstone-004)
- ClinicalTrials.gov ID
- NCT05794659
- Acronym / sponsor ID
- Cornerstone4 / PN-201-22
- Conditions
- Advanced Ovarian Cancer
- Keywords
- cancer vaccine, phase 2 study, Advanced ovarian cancer, homologous-recombination proficient (HRP)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Aston Sci. Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 3 Apr 2023 (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 phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine AST-201 (pUMVC3-hIGFBP-2) in patients with newly diagnosed homologous-recombination proficient(HRP) advanced ovarian cancer (Stage III) after debulking surgery. Patients will receive AST-201 with rhuGM-CSF(Colony Stimulating Factor) or placebo with rhuGM-CSF in combination with standard adjuvant chemotherapy(Paclitaxel/Carboplatin).
Detailed description
The study will comprise a screening period of -28 Days prior to initiation of study treatment (Day 1); an enrollment period of 24 months; the treatment duration will be approximately of 5 months.
The study will evaluate whether the addition of AST-201/rhuGM-CSF to the standard adjuvant chemotherapy will extend the Progression Free Survival(PFS) rate. Survival follow-up will be performed every 3 months (±14 days) after the End of treatment (EOT) visit for 2 years after randomization and every 6 months (±28 days) thereafter until disease progression or death from any cause or withdrawal of consent whichever comes first. Survival follow-up visits will be conducted by telephone, in-person visit, or chart review. The end of study (EOS) is defined as 2 years after the date of last patient enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blind, randomized, placebo-controlled, multicenter, phase 2 clinical study
| Arm | Type | Receives |
|---|---|---|
| AST-301 | Experimental | Biological: AST-201, Drug: Paclitaxel, Drug: Carboplatin, Drug: rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)AST-201 with rhuGM-CSF (3-week interval, 3 cycles in total) Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total) * Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles |
| Placebo | Placebo comparator | Drug: Paclitaxel, Drug: Carboplatin, Drug: Placebo, Drug: rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)Placebo with rhuGM-CSF (3-week interval, 3 cycles in total) Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total) *Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed stage III (FIGO classification) epithelial ovarian cancer including primary peritoneal cancer, fallopian-tube cancer
- Has received upfront surgery and optimally debulked(a residual tumor less than 1 cm)
- Can start adjuvant therapy within 6 weeks of debulking surgery
- Has Homologous Recombination Proficiency (HRP) tumor defined by FDA-approved testing
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (6 listed)
- Has a history of hypersensitivity or other contraindications to rhuGM-CSF
- Has a history of active malignancy ≤5 years prior to first administration of investigational drug except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease
- Is on immune suppression therapy or has a history of immune suppression therapy ≤4 weeks prior to the first administration of investigational drugs
- Has active or prior autoimmune disease or inflammatory disease
- Has active infectious disease 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-201Also: pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccinei.d. (3-week interval, 3 cycles in total) | Biological | AST-301 |
| PaclitaxelAlso: Taxol3-week interval, 6 cycles in total | Drug | AST-301, Placebo |
| CarboplatinAlso: Paraplatin3-week interval, 6 cycles in total | Drug | AST-301, Placebo |
| PlaceboAlso: Normal saline (USP)i.d. (3-week interval, 3 cycles in total) | Drug | Placebo |
| rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)Also: sargramostim, Leukinei.d. (3-week interval, 3 cycles in total) | Drug | AST-301, Placebo |
Primary outcome
Progression-Free Survival (PFS)
Time frame: overall study duration (approximately 48 months)
the time from the date of randomization to disease progression, or death from any cause whichever occurs first
4 secondary outcomes
2-year PFS rate
Time frame: 24months from the first dose of AST-301 administration
Overall Survival (OS)
Time frame: overall study duration (approximately 48 months)
AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot )
Time frame: 17months
Number of participants with Adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0)
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 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.
Hun Jung, MD, PhD study director
jhun@astonsci.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AST-201, Paclitaxel and Carboplatin in people with Advanced Ovarian Cancer, run by Aston Sci. Inc. at 1 site in United States.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung Hun, MD, PhD (+82-2-2038-2347, jhun@astonsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: overall study duration (approximately 48 months)). 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 27 Oct 2026.