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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Aston Sci. Inc.
Study ID
NCT05794659
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Ovarian Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AST-201 — BIOLOGICAL
    i.d. (3-week interval, 3 cycles in total)
  • Paclitaxel — DRUG
    3-week interval, 6 cycles in total
  • Carboplatin — DRUG
    3-week interval, 6 cycles in total
  • Placebo — DRUG
    i.d. (3-week interval, 3 cycles in total)
  • rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor) — DRUG
    i.d. (3-week interval, 3 cycles in total)

Study Details

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).

Key Dates

Start date
Nov 15, 2023
Status verified
Jul 2023
Primary completion
Nov 15, 2025
Completion
Nov 15, 2027

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AST-301
    AST-201 with rhuGM-CSF (3-week interval, 3 cycles in total) Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total) \* Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles
  • Placebo Comparator: Placebo
    Placebo with rhuGM-CSF (3-week interval, 3 cycles in total) Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total) \*Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: overall study duration (approximately 48 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98109
John B. Liao, MD, PhD

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By research site
University of Washington· Seattle, WA

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