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

NCT05794659 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PN-201-22
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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).

Conditions

Advanced Ovarian Cancer

Keywords

cancer vaccine; phase 2 study; Advanced ovarian cancer; homologous-recombination proficient (HRP)

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  the time from the date of randomization to disease progression, or death from any cause whichever occurs first

  overall study duration (approximately 48 months)

Secondary Outcomes (4)

• 2-year PFS rate

  24months from the first dose of AST-301 administration

• Overall Survival (OS)

  overall study duration (approximately 48 months)

• AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot )

  17months

• Number of participants with Adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0)

  5 months

Study Arms (2)

AST-301

EXPERIMENTAL

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

Biological: AST-201; Drug: Paclitaxel; Drug: Carboplatin; Drug: rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)

Placebo

PLACEBO COMPARATOR

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

Drug: Paclitaxel; Drug: Carboplatin; Drug: Placebo; Drug: rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)

Interventions

AST-201 BIOLOGICAL

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

Also known as: pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine

AST-301

Paclitaxel DRUG

3-week interval, 6 cycles in total

Also known as: Taxol

AST-301; Placebo

Carboplatin DRUG

3-week interval, 6 cycles in total

Also known as: Paraplatin

AST-301; Placebo

Placebo DRUG

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

Also known as: Normal saline (USP)

Placebo

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

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

Also known as: sargramostim, Leukine

AST-301; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aston Sci. Inc.: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Paclitaxel; Carboplatin; Saline Solution; sargramostim

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hyunwon Shin, MD, PhD

  hyunwon.shin@astonsci.com

  STUDY DIRECTOR

Central Study Contacts

Hyunwon Shin, MD, PhD

CONTACT

+82-2-2038-2347; hyunwon.shin@astonsci.com

Eunkyo Joung, MD, CMO

CONTACT

+82-2-2038-2347; eunkyo.joung@astonsci.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single blind, randomized, placebo-controlled, multicenter, phase 2 clinical study

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 3, 2023
• Study Start: November 15, 2023
• Primary Completion: November 15, 2025
• Study Completion (Estimated): November 15, 2027
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)