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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05794659
Other study ID # PN-201-22
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date November 15, 2023
Est. completion date November 15, 2027

Study information

Verified date July 2023
Source Aston Sci. Inc.
Contact Hyunwon Shin, MD, PhD
Phone +82-2-2038-2347
Email hyunwon.shin@astonsci.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 98
Est. completion date November 15, 2027
Est. primary completion date November 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Biological:
AST-201
i.d. (3-week interval, 3 cycles in total)
Drug:
Paclitaxel
3-week interval, 6 cycles in total
Carboplatin
3-week interval, 6 cycles in total
Placebo
i.d. (3-week interval, 3 cycles in total)
rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)
i.d. (3-week interval, 3 cycles in total)

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Aston Sci. Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2-year PFS rate proportion of patients alive without disease progression or death at two years after the randomization 24months from the first dose of AST-301 administration
Secondary Overall Survival (OS) the time from the date of randomization to death from any cause overall study duration (approximately 48 months)
Secondary AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot ) AST-201 specific IFN-gamma ELISpot 17months
Secondary 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 5 months
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