NCT05794659

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

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Aston Sci. Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Advanced Ovarian Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-11-15
• Primary completion: 2025-11-15
• Completion: 2027-11-15
• First posted: 2023-04-03
• Last updated: 2023-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study