Skip to main content
Advanced Ovarian CancerCancerBiologicalDrugPhase 2

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 ↗