Phase 2
Completed N=20
FLX475 Combined With Pembrolizumab in Patients With Advanced or Metastatic Gastric Cancer
Source: ClinicalTrials.gov NCT04768686 ↗Enrolled (actual)
20
Serious AEs
35.0%
Results posted
Sep 2025
Primary outcomePrimary: Overall Response Rate (ORR) in Subjects Treated With FLX475 in Combination With Pembrolizumab — 0; 60.0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) in Subjects Treated With FLX475 in Combination With Pembrolizumab |
0; 60.0 | — |
| SECONDARY Disease Control Rate (DCR) in Subjects Treated With FLX475 in Combination With Pembrolizumab |
20.0; 60.0 | — |
| SECONDARY Time to Response (TTR) in Subjects Treated With FLX475 in Combination With Pembrolizumab |
NA; 2.7 | — |
| SECONDARY Duration of Response (DoR) in Subjects Treated With FLX475 in Combination With Pembrolizumab |
17.3 | — |
| SECONDARY Progression-free Survival (PFS) in Subjects Treated With FLX475 in Combination With Pembrolizumab |
1.4; 10.4 | — |
| SECONDARY Overall Survival (OS) in Subjects Treated With FLX475 in Combination With Pembrolizumab |
7.5; NA | — |
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
Data sourced from ClinicalTrials.gov (NCT04768686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.