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

NCT ID: NCT05794659

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2027-11-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

AST-201

Intervention Type: BIOLOGICAL

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

Paclitaxel

Intervention Type: DRUG

3-week interval, 6 cycles in total

Carboplatin

Intervention Type: DRUG

3-week interval, 6 cycles in total

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

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Paclitaxel

Intervention Type: DRUG

3-week interval, 6 cycles in total

Carboplatin

Intervention Type: DRUG

3-week interval, 6 cycles in total

Placebo

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

Interventions

AST-201

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

Intervention Type: BIOLOGICAL

Paclitaxel

3-week interval, 6 cycles in total

Intervention Type: DRUG

Carboplatin

3-week interval, 6 cycles in total

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Other Intervention Names

pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine; Taxol; Paraplatin; Normal saline (USP); sargramostim; Leukine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aston Sci. Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyunwon Shin, MD, PhD

Role: STUDY_DIRECTOR

hyunwon.shin@astonsci.com

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Central Contacts

Hyunwon Shin, MD, PhD

Role: CONTACT

hyunwon.shin@astonsci.com

+82-2-2038-2347

Eunkyo Joung, MD, CMO

Role: CONTACT

eunkyo.joung@astonsci.com

+82-2-2038-2347

Facility Contacts

John B. Liao, MD, PhD

Role: primary

Other Identifiers

PN-201-22

Identifier Type: -

Identifier Source: org_study_id