What this study is
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).
What's being tested
- AST-201
Intervention · BIOLOGICAL
- Paclitaxel
Intervention · DRUG
- Carboplatin
Intervention · DRUG
- Placebo
Intervention · DRUG
- rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)
Intervention · DRUG
All of AST-201, Placebo, rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)
i.d. (3-week interval, 3 cycles in total)
Both Paclitaxel and Carboplatin
3-week interval, 6 cycles in total
Study details
- 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)
- Sponsor
- Aston Sci. Inc.
- Conditions
- Advanced Ovarian Cancer
- Enrolling
- 98 people
- Starts
- 2027-06-01
- Est. completion
- 2031-06-01
- Design
- Single-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openUniversity of Washington
Seattle, Washington, United States
- John B. Liao, MD, PhD · Contact
Study team
Sponsor
Aston Sci. Inc.
Study ID PN-201-22
Study director
Hun Jung, MD, PhD
jhun@astonsci.com
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.