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

Sponsor: Aston Sci. Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05794659

Patient View

This phase 2 study evaluates the efficacy and safety of AST-201 with rhuGM-CSF versus placebo in HRP advanced ovarian cancer post-debulking surgery. Participants receive AST-201 or placebo with standard chemotherapy (Paclitaxel/Carboplatin). Eligibility includes stage III diagnosis, optimal debulking, HRP status, and ECOG 0-1. The study spans 5 months with follow-up for progression or survival.

Patient Parameters

Program Overview

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).

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.

Eligibility 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

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