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Clinical Trials in the USA / NCT05794659
Starting soon Phase 2

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

NCT05794659 · tracked via the Priya Life Science USA tracker
Sponsor
Aston Sci. Inc.
Phase
Phase 2
Started
2023-11-15
Last updated
2023-07-20

Condition(s) studied

Advanced Ovarian Cancer

Investigational drug(s) / intervention(s)

AST-201PaclitaxelCarboplatinPlaceborhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)

AST-201: i.d. (3-week interval, 3 cycles in total)

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)

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University of Washington Seattle Washington

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05794659 on ClinicalTrials.gov ↗ ← All trials in the USA