CLDN18.2-positive and HER2-negative gastric or gastroesophageal junction adenocarcinoma
Conditions
Interventions
1. Zolbetuximab
If there is no prior history of administration, 800 mg/m2 should be administered intravenously for the first dose, and 400 mg/m2 for the second and subsequent doses at 2-week intervals
Sponsors
Maeda Osamu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Unresectable or recurrent gastric or gastro-esophageal junction adenocarcinoma (2) CLDN18.2 positive and HER2 negative (3) Completed first-line therapy including a fluoropyrimidine-based anticancer drug and second-line or subsequent therapy (with or without prior zolbetuximab administration) (4) If there is a history of administration of trifluridine/tipiracil, or if it has been administered, there has been no observed tumor progression during the administration of trifluridine/tipiracil. (5) Age 18 years and older (6) Performance Status (PS) 0 to 1 (7) Neutrophil count>=1,500/mm3 (8) Platelet count >=75,000/mm3 (9) Hemoglobin >=8.0 g/dL (acceptable for blood transfusion) (10) AST (GOT) <=100 IU/L (<=200 IU/L in case of liver metastasis) (11) ALT (GPT) <=100 IU/L (<=200 IU/L in case of liver metastasis) (12) Total bilirubin <=1.5 mg/dL (13) Creatinine <=1.5 mg/dL (14) Peripheral neuropathy<= Grade 2 (15) Diarrhea <=Grade 1 (16) Non-hematologic toxicity other than alopecia, dysgeusia, hyperpigmentation, and symptoms associated with the primary disease <=Grade 1 (17) No active infection (18) Women who may become pregnant must use appropriate contraception (either oral contraceptives (progestin-estrogen combination products), intrauterine devices, or condoms for male partners) during and for 6 months after the final administration of trifluridine/tipiracil. (19) Men must use condoms for contraception during and for 3 months after the final administration of trifluridine/tipiracil.
Exclusion criteria
Exclusion criteria: (1) Patients with tumor progression during treatment with trifluridine/tipiracil (2) Trifluridine tipiracil was discontinued due to severe hypersensitivity and other side effects. (3) Patient has a history of anaphylaxis, suspected anaphylaxis, Grade 3 or higher hypersensitivity or infusion reaction, or Grade 4 vomiting, if previously treated with zolbetuximab (4) Pregnant patients or those who may be pregnant, or breastfeeding patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent events leading to discontinuation of zolbetuximab during the study treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to treatment-failure, progression-free survival, overall survival, response rate, incidence of adverse events, and incidence of Grade 3 or higher adverse events | — |
Contacts
Public ContactOsamu Maeda
Nagoya University Hospital
Outcome results
None listed