Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer

• Status: Not yet recruiting
• Trial end date: 2027-08-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aston Sci. Inc.
• Treatments: Carboplatin; Molgramostim; Paclitaxel; Sargramostim

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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