drugset / Trial / NCT05794659
Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer
RandomizedParallel-groupSingle-blindTreatment
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. Patients will receive AST-201 with rhuGM-CSF(Colony Stimulating Factor) or placebo with rhuGM-CSF in combination with standard adjuvant chemotherapy(Paclitaxel/Carboplatin).
Timeline
- Start
- 2023-11-15
- Primary completion
- 2025-11-15
- Completion
- 2027-11-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AST-201 | Vaccine | — | Other |
| Background | Carboplatin | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | sargramostim | Protein / enzyme biologic | — | Other |