Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer
ConditionGastric Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAston Sci. Inc.
About this trial
The purpose of this early proof-of-concept study to evaluate the safety and immunologic efficacy of AST-301 in gastric cancer patients with HER2 expression (including both HER2 low expression and overexpression) who have completed the standard adjuvant treatment (including those who discontinued the standard adjuvant treatment due to intolerance).
Participants will be randomized 1:1 to either Arm 1 (Q3W, 3 cycles), or Arm 2 (Q3W, 6 cycles) of the study.
Safety Monitoring Committee (SMC) will oversee safety of study at 25% (6 participants), 50% (12 participants), and 75% (18 participants) of participants receive at least 1 dose of AST-301 and survival follow up will be performed to determine disease-free survival (DFS).
Eligibility criteria
Qualifiers
Underwent a curative surgery with standard lymph node dissection (confirmed with no residual tumor, R0 resection) and have completed standard adjuvant treatment
Has stages II or III according to the 8th edition of the American Joint Committee on Cancer (AJCC)
HER2 low expression and HER2 overexpression diagnosed according to the 2016 College of American Pathologists (CAP)/American Society for Clinical Pathology (ASCP)/American Society of Clinical Oncology (ASCO) guidelines
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Disqualifiers
Has a history of hypersensitivity or other contraindications to rhuGM-CSF
Has a history of other malignancies ≤5 years prior to first administration of Investigational Product (IP) except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease.
Has received systemic immunosuppressants or were treated with systemic immunosuppressants ≤4 weeks prior to the first administration of Investigational Product (IP).
Has a history of autoimmune disease or inflammatory disease
Trial design
Treatments tested in this trial
- AST-301
- rhuGM-CSF
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov