Status:
COMPLETED
FLX475 Combined With Pembrolizumab in Patients With Advanced or Metastatic Gastric Cancer
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This clinical study is a Phase 2, open-label study to assess the efficacy, safety profile of FLX475 combined with pembrolizumab in patients with advanced or metastatic gastric cancer. This study is de...
Eligibility Criteria
Inclusion
- All patients must have histologically or cytologically confirmed, advanced, relapsed or metastatic gastric or gastroesophageal junction adenocarcinoma
- Patient must have one of the following diagnoses to be eligible for enrollment into cohorts:
- Cohort 1: Checkpoint inhibitor naïve Epstein-Barr Virus negative (EBV-) gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer
- Cohort 2: Checkpoint inhibitor naïve Epstein-Barr virus positive (EBV+) gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Patient must have at least one measurable lesion at baseline by computed tomography(CT) or magnetic resonance imaging (MRI)
- Tumor available for biopsy
Exclusion
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137), any history of discontinuing from that treatment due to Grade 3 or higher immune-related adverse event (irAE)
- Patient with MSI-H status
- Active autoimmune disease or serious autoimmune disease within past 2 years requiring systemic therapy
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required steroids, or clinical symptoms of active pneumonitis
- Significant cardiovascular disease. New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, or chronic Grade 3 hypertension.
- Significant screening electrocardiogram (ECG) abnormalities
- Has had an allogenic tissue/solid organ transplant
Key Trial Info
Start Date :
May 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04768686
Start Date
May 18 2021
End Date
August 12 2024
Last Update
September 25 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Hanllym University Medical Center
Anyang-si, Gyeonggi-do, South Korea
2
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
3
The Catholic University of Korea St. Vincent Hospital
Suwon, Gyeonggi-do, South Korea
4
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea