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NOT YET RECRUITING
NCT05794659
PHASE2

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

Sponsor: Aston Sci. Inc.

View on ClinicalTrials.gov

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).

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2023-11-15

Completion Date

2027-11-15

Last Updated

2023-07-20

Healthy Volunteers

No

Interventions

BIOLOGICAL

AST-201

i.d. (3-week interval, 3 cycles in total)

DRUG

Paclitaxel

3-week interval, 6 cycles in total

DRUG

Carboplatin

3-week interval, 6 cycles in total

DRUG

Placebo

i.d. (3-week interval, 3 cycles in total)

DRUG

rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)

i.d. (3-week interval, 3 cycles in total)

Locations (1)

University of Washington

Seattle, Washington, United States