Esophageal Cancer,Gastric Cancer,Pancreatic Cancer,Colorectal Cancer,Solid Tumor
Conditions
Interventions
Experimental: BL-M17D1:BL-M17D1 injection
Sponsors
hunan cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Voluntarily sign the informed consent and follow the requirements of the protocol; 2: No gender limit; 3: Age: =18 years old and =75 years old (stage la); 1.=18 years old (stage lb); 4:Expected survival time =3 months; 5: The pathologic histolgy and/or cytology diagnosis of localy advanced or metastatic positive HER2 /low expression ofthe digestive tract tumor and other solid tumor 6: Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years, 7: Must have at least one measurable lesion according to REClST v1.1 definition; 8: ECOG 0 or 1; 9: Toxicity of previous antineoplastic therapy has returned to = grade 1 defined by NCI-CTCAE V5.0; 10:No severe cardiac dysfunction, left ventricular ejection fraction =50%6; 11:Oraan function level must meet the requirements: 12: Coagulation function: international normalized ratio s1.5, and activated partial thromboplastin time s1.5ULN 13: Urine protein =2+ or s1000mg/24h 14: For premenopausal women with childbeaning potential, a pregnancy tet must be performed within 7 days before the initiation of treatment, serum pregnancy musi be negative, and must be non-lactating; All the patients (no mater male or female) shall be 6 months after the end ofthe treatment peniod and ful barier precautions.
Exclusion criteria
Exclusion criteria: 1. Use of anti-tumor therapies such as chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule tyrosine kinase inhibitors) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose; Mitomycin and nitrosoureas within 6 weeks prior to the first dose; Fluorouracil oral medications such as tigio, capecitabine, or palliative radiotherapy within 2 weeks prior to the first dose; 2. Prior receipt of ADCs with MMAE/MMAF as toxin; 3. History of severe heart disease, such as: history of symptomatic congestive heart failure (CHF) = grade 2 (CTCAE 5.0), New York Heart Association (NYHA) grade = 2 heart failure, history of transmural myocardial infarction, unstable angina, etc.; 4. QT interval prolongation (QTc>450 msec for males or QTc>470 msec for females, QTc interval calculated on Fridericia scale), complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias: such as atrial fibrillation, atrial flutter, ventricular fibrillation, ventricular flutter (except for transient atrial fibrillation, atrial flutter or stable for 2 weeks after treatment with anti-arrhythmic drugs); 5. Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc., except type I diabetes mellitus, hypothyroidism that can be controlled by replacement therapy only, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis); 6. Diagnosis of other malignancies within 5 years prior to the first dose, with the following exceptions: radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection; 7. Hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure >100 mmHg) that is poorly controlled by two antihypertensive drugs; 8. Patients with poor glycemic control prior to the first dose, defined as: a) two fasting blood glucose >10mmol/L, or b) glycosylated hemoglobin levels exceeding 8%, c) or other serious complications such as diabetic gangrene; 9. Has a history of interstitial lung disease (ILD) requiring hormonal therapy (including pulmonary fibrosis or radiation pneumonitis), or currently has ILD or radiation pneumonitis of =1 as defined by RTOG/EORTC, or is suspected of having such disease by imaging during the screening period; 10. Concurrent pulmonary disease resulting in clinically severe respiratory impairment, including but not limited to the following: a. any underlying pulmonary disease (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease within 3 months prior to randomization), b. restrictive lung disease; 11. Patients with a large amount of serosal effusion, or symptomatic serous effusion, or poorly controlled serous effusion (poorly controlled is defined as 2 or more puncture drainage within 1 month); 12. Imaging examination shows that the tumor has invaded or encircled the chest, neck, pharynx and other large blood vessels, except for those that the investigator believes will not affect the patient's enrollment and medication; 13. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within 6 months prior to screenin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose;Dose limiting toxicity (DLT); | — |
Countries
China
Contacts
Public ContactYongchang zhang
hunan cancer hospital
Outcome results
None listed