Advanced Gastric or Gastroesophageal Junction Cancer
Conditions
Interventions
- Bemarituzumab (15mg/kg, intravenous, Day1, 15, q4w)
(C1D8 7.5 mg/kg, intravenous)
- Paclitaxel (80 mg/m2, intravenous, Day1, 8, 15, q4w)
- Ramucirumab (8 mg/kg, Day 1, 15, q4w)
Sponsors
Hirata Kenro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically documented gastric or GEJ adenocarcinoma whose disease is unresectable, locally advanced, or metastatic (not amendable to curative therapy) 2) FGFR2b >= 10% 2+/3+ tumor cells as determined by VENTANA FGFR2b (FPR2-D) RxDx Assay testing, based on tumor sample either archival or a fresh biopsy 3) Subject must have at least one measurable lesion by CT or MRI per RECIST 1.1 criteria 4) Subject has experienced documented objective radiographic or clinical disease progression during first-line therapy with fluoropyrimidine-containing regimen for unresectable or metastatic disease 5) Age >= 18 years 6) Eastern Cooperative Oncology Group (ECOG) ECOG Performance status (PS) of 0 to 1 7) Adequate organ function as follows : - Organ system function evaluation should be performed within 14 days prior to enrollment, and the findings should be within the following parameters - Transfusion of blood or granulocyte colony-stimulating factor (G-CSF) within a week is not acceptable 8) Subjects with treatment-free period as follows : - Major surgical procedure : 28 days - Radiotherapy : 14 days 9) Women of childbearing potential must have a negative pregnancy test within 14 days prior to enrollment (test results on the same day of the week 14 days prior to enrollment are acceptable). Both men and women have agreed to use adequate contraception from the time of obtaining consent to a certain period of time after the final application of protocol treatment (9 months for women and 6 months for men after the last dose of protocol-mandated therapy) 10) Subjects has provided informed consent prior to enrollment in the study
Exclusion criteria
Exclusion criteria: 1) Prior treatment with taxanes 2) Prior treatment with any selective inhibitor of FGF-FGFR pathway or VEGF-VEGFR pathway 3) Untreated or symptomatic central nerve system (CNS) metastases and leptomeningeal disease 4) Evidence of, or recent (within 6 months) history of, corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer 5) The patient has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months. Patients with deep vein thrombosis with adequate anticoagulant therapy is allowed for registration 6) Impaired cardiac function or clinically significant cardiac disease including : unstable angina within 6 months prior to first dose of study treatment, acute myocardial infarction = 470 msec 7) History of other malignancy within the past 3 years 8) Subjects with severe complications (i.e., intestinal paralysis, bowel obstruction, uncontrolled diabetes mellitus, heart failure, myocardial infarction, unstable angina, renal failure, liver failure, psychiatric disorders, cerebrovascular disease) 9) Subjects whose adverse events have not resolved to Grade <= 1 or baseline expect for epilation 10) History of gastrointestinal perforation and/or fistulae within 6 months 11) Known hepatitis B infection (subjects with hepatitis B surface antigen [HBsAg] or core antibody that achieve sustained virologic response with antiviral therapy directed at hepatitis B are allowed), known hepatitis C infection (subjects with hepatitis C RNA detection), and human immunodeficiency virus (HIV) infection with CD4+ T-cell (CD4+) counts < 350 cells/microliter 12) History of severe lung disease with the necessity of treatment (i.e. intestinal lung disease, pneumonitis, or pulmonary fibrosis) 13) Subjects who require continuous systemic administration (intake or injection) of corticosteroids higher than 10 mg/day of prednisolone equivalent due to the reasons other than endocrine or autoimmune diseases and those who require immunosuppressive agents. The temporary use for prevention of allergy or edema induced by radiotherapy is allowed 14) The patient has a serious or non healing wound or peptic ulcer or bone fracture 15) Active infection requiring systemic treatment with antibiotics, antiviral therapy, or antifungal drug 16) History of vaccination with a live vaccine (mRNA vaccines and replication-deficient adenovirus vaccines are not considered live vaccines) within 30 days prior to the initiation of study treatment 17) Female subjects who are pregnant or breastfeeding 18) Subjects who are unwilling to practice appropriate contraception during treatment and for an additional period prespecified in the study protocol 19) Male subjects unwilling to abstain from donating sperm during treatment and for an additional 6 months after the last dose of protocol-mandated therapy and female subjects unwilling to abstain from donating egg or egg retrieval for self-use for an additional 9 months after the last dose of protocol-mandated therapy 20) Known severe allergy or hypersensitivity to components of the study drugs 21) Known severe allergy or hypersensitivity to other mono
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) by central assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR by investigators, Progression-free survival by BICR and investigators, Duration of response by BICR and investigators, Disease control rate by BICR and investigators, Overall survival, Safety | — |
Contacts
Public ContactKen Mizushima
West Japan Oncology Group
Outcome results
None listed