Clinical trial NCT04768686: FLX475 Combined with Pembrolizumab in Patients with Advanced or Metastatic Gastric Cancer
Official title: A Phase 2 Study to Assess the Safety, Efficacy of FLX475 Combined with Pembrolizumab in Patients with Advanced or Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2021-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 designed to assess the potential anti-tumor activity when administered at the 100mg QD of FLX475 with pembrolizumab and will be conducted (2) cohorts as detailed below.

* Cohort 1: EBV negative / CPI naïve gastric cancer subjects who have progressed on at least 2 prior systemic treatments for advanced or metastatic gastric cancer
* Cohort 2: EBV positive / CPI naïve gastric cancer subjects who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer

Approximately 90 subjects may be enrolled across two cohorts to examine the safety and efficacy.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Overall response rate in subjects treated with FLX475 in combination with pembrolizumab
timeFrame: Through study completion (approximately 2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hanllym University Medical Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si,
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent Hospital
state: Gyeonggi-do
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: