Phase 2
Completed N=155
A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer
Source: ClinicalTrials.gov NCT03694522 ↗Enrolled (actual)
155
Serious AEs
35.3%
Results posted
May 2022
Primary outcomePrimary: Progression-Free Survival (PFS) — 9.5; 7.4 months — p=0.0727
Summary
The main objective of the Phase 2 part of the study is to evaluate the efficacy of bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
9.5; 7.4 | 0.0727 |
| SECONDARY Overall Survival (OS) |
NA; 12.9 | 0.0268 sig |
| SECONDARY Overall Response Rate (ORR) |
46.8; 33.3 | 0.1060 |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
76; 76; 63; 58; 72; 73 | — |
Eligibility Criteria
Key Inclusion Criteria
- Histologically documented gastric or gastroesophageal junctional adenocarcinoma (not amenable to curative therapy)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate hematological, liver and kidney function. Measurable or non-measurable, but evaluable disease using RECIST v1.1
- Fibroblast growth factor receptor 2b (FGFR2b) overexpression as determined by a centrally performed immunohistochemistry tissue test and/or FGFR2 gene amplification as determined by a centrally performed circulating tumor deoxyribonucleic acid (ctDNA) blood based assay
- Candidate for mFOLFOX6 chemotherapy
Key Exclusion Criteria
- Untreated or symptomatic central nervous system (CNS) metastases
- Clinically significant cardiac disease,
- Peripheral sensory neuropathy >/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
- Active infection requiring systemic treatment
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection
- Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
- Known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
- Known positivity for human epidermal growth factor receptor 2 (HER2)
- Women who are pregnant or breastfeeding
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03694522). 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.