Metastatic gastric/gastroesophageal junction adenocarcinoma
Conditions
Interventions
Cohort 1- Phase 1 (Q3W):Recombinant HER2 Humanized Monoclonal Antibody Monomethyl Oretin F-Conjugate (FS-1502), 2.3 mg/kg, injection, Q3W
Cohort 2- Phase 1 (Q3W):Recombinant HER2 Humanized Monoclonal Antibody Monomethyl Oretin F-Conjugate (FS-1502), 2.3 mg/kg, injection, Q3W
Cohort 1- Phase 1 (Q2W) :Recombinant HER2 Humanized Monoclonal Antibody Monomethyl Oretin F-Conjugate (FS-1502), 2.3 mg/kg, injection, Q2W
Cohort 2- Phase 1 (Q2W) :Recombinant HER2 Humanized Monoclonal Antibody Monomethyl Oretin F-Conjugate (FS-1502), 2.3 mg/kg, injection, Q2W
Sponsors
Sir Run Run Shaw Hospital , Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old (including 18 years old and 80 years old); 2. HER2 overexpression, locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma: HER2 overexpression, defined as histological IHC 3 or IHC 2: Subjects are required to provide paraffin sections prepared from tumor tissue that have been confirmed by central laboratory testing before they can be enrolled. Cohort 1: Histologically and/or cytologically confirmed locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma with at least 2 prior systemic regimens (patients who have relapsed and progressed within 6 months after adjuvant therapy or neoadjuvant therapy are counted as one line of therapy). Cohort 2: Histologically and/or cytologically confirmed locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma with 1 prior systemic regimen (patients who have relapsed and progressed within 6 months after adjuvant therapy or neoadjuvant therapy are counted as one line of therapy). 3. Expected survival >=12 weeks; 4. Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1; 5. Patient has adequate organ and bone marrow function: Absolute neutrophil value >=1.5×10^9/L (no G-CSF treatment within 7 days); hemoglobin > = 90 g/L; Platelet >=100×10^9/L; Serum potassium >=3.5 mmol/L; albumin >=30g/L; Urine protein =60 ml/min, Creatinine clearance was calculated using the Cockcroft-Gault formula. 6. According to RECIST version 1.1 criteria, at least one measurable lesion, and the measurable lesion should not have received local therapy such as radiotherapy (lesions located in the area of previous radiotherapy, if progression is confirmed, it can also be used as a target lesion); 7. Females of childbearing potential must have a negative serum pregnancy test within 28 days prior to the first dose of study drug and agree to practice one medically approved form of contraception (such as an intrauterine device, birth control pill, or condom) from 28 days prior to the first dose of study drug to 3 months after the last dose of study drug; Male patients need to undergo ligation surgery or agree to contraception and refuse sperm donation from 7 days before the first dose to 3 months after the last dose; 8. Able to understand and willing to sign an informed consent form prior to initiation of any study procedures.
Exclusion criteria
Exclusion criteria: 1. Received chemotherapy, targeted therapy, radiotherapy, etc., within 14 days or 5 half-life periods (whichever is shorter) before the initiation of dose; Patients who received major surgery, tumor immunotherapy, or monoclonal antibody anti-tumor drugs within 4 weeks before the initiation of drug administration; 2. Patients with leptomeningeal metastases, spinal cord metastases and clinically symptomatic brain parenchymal metastases. Subjects were allowed to enroll if they met three of the following conditions: treated for brain metastases and stable for at least 6 months; Absence of disease progression and new or expanding brain metastases as determined by imaging within 4 weeks before dosing; Absence of neurological symptoms and steroid therapy; 3. The toxicity of previous antineoplastic therapy has not recovered to NCI-CTCAE 5.0 grade 1 (alopecia and pigmentation were allowed); 4. patients with stable uncontrolled diabetes (patients receiving stable insulin or antidiabetic regimens or with good glycemic control as assessed by specialists); 5. QTcF > 470 msec (measured according to Fridericia's formula on 12-lead electrocardiography at screening), LVEF 150 mmHg, and/or diastolic blood pressure >100 mmHg; New York Heart Association (NYHA) grade =3 congestive heart failure; Clinically significant arrhythmias, including but not limited to complete left bundle branch conduction abnormalities, degree II atrioventricular block; Occurrence of major arterial/venous thrombotic events within 1 year prior to study administration, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, pulmonary embolism, myocardial infarction, etc.; 10. Active infections requiring systemic treatment (including active tuberculosis); 11. Patients with active hepatitis B (HBsAg positive and HBV-DNA=1000IU/ml or 1000cps/ml or meet the study center criteria for active hepatitis B infection) or hepatitis C (positive HCVAb); The HIV test result was positive. 12. Presence of uncontrolled third space effusion (including massive pleural effusion, massive pericardial effusion and massive ascites); Pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt or concentrated acellular ascites reinfusion therapy (CART); Drainage and CART should not be performed for 2 weeks before the screening assessment. 13. Hypersensitivity reaction or delayed hypersensitivity reaction to some components of FS-1502 or similar drugs; 14. Other malignant tumors (non-melanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ, or other tumors that have been effectively treated, except malignant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate(investigator); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);overall survival (OS);time to tumor response (TTR);duration of response (DOR);Duration of response (DOR);Disease control rate (DCR); | — |
Countries
China
Contacts
Public ContactPan Hongming
Sir Run Run Shaw Hospital , Zhejiang University School of Medicine
Outcome results
None listed