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Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer (Cornerstone4)

Primary Purpose

Advanced Ovarian Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AST-201
Paclitaxel
Carboplatin
Placebo
rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)
Sponsored by
Aston Sci. Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Ovarian Cancer focused on measuring cancer vaccine, phase 2 study, Advanced ovarian cancer, homologous-recombination proficient (HRP)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AST-301

Placebo

Arm Description

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 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

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
the time from the date of randomization to disease progression, or death from any cause whichever occurs first

Secondary Outcome Measures

2-year PFS rate
proportion of patients alive without disease progression or death at two years after the randomization
Overall Survival (OS)
the time from the date of randomization to death from any cause
AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot )
AST-201 specific IFN-gamma ELISpot
Number of participants with Adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0)
Adverse events (AEs) Treatment-emergent adverse events (TEAEs) Serious adverse events (SAEs) Vital signs Physical examination Eastern Cooperative Oncology Group (ECOG) performance status Electrocardiogram (ECG) test Laboratory tests

Full Information

First Posted
March 7, 2023
Last Updated
July 18, 2023
Sponsor
Aston Sci. Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05794659
Brief Title
Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer
Acronym
Cornerstone4
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2023 (Anticipated)
Primary Completion Date
November 15, 2025 (Anticipated)
Study Completion Date
November 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aston Sci. Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Ovarian Cancer
Keywords
cancer vaccine, phase 2 study, Advanced ovarian cancer, homologous-recombination proficient (HRP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Single blind, randomized, placebo-controlled, multicenter, phase 2 clinical study
Masking
Participant
Masking Description
Single blinded
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AST-301
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
AST-201
Other Intervention Name(s)
pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine
Intervention Description
i.d. (3-week interval, 3 cycles in total)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
3-week interval, 6 cycles in total
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
3-week interval, 6 cycles in total
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline (USP)
Intervention Description
i.d. (3-week interval, 3 cycles in total)
Intervention Type
Drug
Intervention Name(s)
rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)
Other Intervention Name(s)
sargramostim, Leukine
Intervention Description
i.d. (3-week interval, 3 cycles in total)
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
the time from the date of randomization to disease progression, or death from any cause whichever occurs first
Time Frame
overall study duration (approximately 48 months)
Secondary Outcome Measure Information:
Title
2-year PFS rate
Description
proportion of patients alive without disease progression or death at two years after the randomization
Time Frame
24months from the first dose of AST-301 administration
Title
Overall Survival (OS)
Description
the time from the date of randomization to death from any cause
Time Frame
overall study duration (approximately 48 months)
Title
AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot )
Description
AST-201 specific IFN-gamma ELISpot
Time Frame
17months
Title
Number of participants with Adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0)
Description
Adverse events (AEs) Treatment-emergent adverse events (TEAEs) Serious adverse events (SAEs) Vital signs Physical examination Eastern Cooperative Oncology Group (ECOG) performance status Electrocardiogram (ECG) test Laboratory tests
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyunwon Shin, MD, PhD
Phone
+82-2-2038-2347
Email
hyunwon.shin@astonsci.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eunkyo Joung, MD, CMO
Phone
+82-2-2038-2347
Email
eunkyo.joung@astonsci.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyunwon Shin, MD, PhD
Organizational Affiliation
hyunwon.shin@astonsci.com
Official's Role
Study Director
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John B. Liao, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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