malignacies
Conditions
Interventions
single group:injection KMHH-03 0.54 mg/kg ivgtt
Sponsors
Shanxi Bethune Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects must meet the following criteria to be eligible for this study: (1) Age =18 years and =70 years (including the lower limit); (2) Pathological histopathology or cytology confirmed metastatic or locally advanced, unresectable malignant tumor, failure of standard therapy or intolerance or no standard therapy available, at least two lines of standard anti-cancer treatment after disease progression, assessed by the investigator as inappropriate for standard therapy (based on the most recent authoritative guidelines for standard therapy); (3) At least one assessable target lesion according to RECIST 1.1 criteria; (4) ECOG performance status 0 or 1; (5) Suitable organs and hematopoietic function, without significant organ dysfunction according to the following laboratory tests: a) Hematology: absolute neutrophil count (ANC) =1.5×10^9/L, platelet count =100×10^9/L, hemoglobin =90 g/L; b) Renal function: serum creatinine =1.5 times the upper limit of normal (ULN) or creatinine clearance rate =50 mL/min (using the Cockcroft-Gault formula for creatinine clearance rate); c) Liver function: AST and ALT =2.5 times the ULN (=5 times the ULN if accompanied by liver metastasis); total bilirubin (TBIL) =1.5 times the ULN, or for participants with total bilirubin >1.5×ULN, direct bilirubin =ULN; alkaline phosphatase =1.5 times the ULN, =5 times the ULN for participants with liver metastasis or bone metastasis; d) Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) =1.5 times the ULN. (6) Expected survival of at least 3 months; (7) No fertility plans within 2 weeks prior to screening and 3 months following the end of the study, and agreement to take effective contraceptive measures during the study period; (8) Voluntarily participate in the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be eligible to enter this trial: (1) A history of allergic reaction, intolerance to peptide-based drugs, or allergy to any component of the trial drug injection solution; (2) Uncontrolled active brain metastases or meningeal metastases: Subjects who require any radiotherapy, surgery, or drug treatment (including corticosteroids, anticonvulsants, etc.) within one month prior to screening to control metastatic symptoms are not eligible for enrollment, while subjects with stable metastatic lesions are eligible; (3) A history of autoimmune diseases requiring treatment with glucocorticoids or immunosuppressive drugs; (4) Uncontrolled comorbidities or cancer-related pain; (5) Hypertension that cannot be controlled by medication (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg); (6) Subjects with a history of serious cardiovascular diseases within 12 months, such as acute myocardial infarction within 12 months, coronary artery bypass grafting or stent implantation, unstable angina, myocarditis, grade III or higher chronic heart failure (according to the New York Heart Association criteria), or electrocardiographic findings of prolonged QT interval (>470 ms for females, >450 ms for males) or serious arrhythmia; (7) Subjects with a history of serious renal diseases, such as chronic nephritis or renal insufficiency; (8) Uncontrolled active infections at present; (9) Participants who test positive for active hepatitis B (HBsAg positive or HBcAb positive with HBV-DNA above the detection limit (i.e., the upper limit of normal value at each center's laboratory)) or active hepatitis C (HCV antibody positive with HCV-RNA above the detection limit (normal value upper limit)) or clinically diagnosed with chronic hepatitis; or participants with HIV antibody screening results positive; or participants with positive TP-Ab and positive RPR; (10) Participants who have had other malignant tumors within the past 5 years, except for cured cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma; (11) Participants who have received other vaccines within 3 months prior to screening or plan to receive vaccines during the trial; (12) Participants who have received systemic steroid treatment within 14 days prior to the first dose and were determined by the investigator to require long-term use of systemic steroid treatment (inhalation or local use, physiological replacement dose excluded); (13) Participants who have participated in any other interventional clinical trial within 28 days prior to the first dose; (14) Participants who have received blood transfusion, recombinant human thrombopoietin (rhTPO), recombinant human interleukin-11 (rhIL-11), erythropoietin (EPO), granulocyte/granulocyte-macrophage colony-stimulating factor (G-CSF/GM-CSF) related treatment within 2 weeks prior to the first dose; (15) Participants who have undergone a major surgery requiring general anesthesia within 4 weeks prior to the first dose; surgery requiring local anesthesia/spinal anesthesia within 2 weeks prior to the first dose that has not yet fully recovered (excluding biopsy); (16) Toxicity from prior antitumor therapy had not resolved to baseline before first administration or NCI-CTCAE v5.0= class 1 (alopecia or other toxicity that the investigator determined was not a safety risk to the subject could be enrolled without recovery); (17) Women preparing for pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The AEs in the trial; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rates of ADA and Nab in the trial;The primary efficacy index: the quantity and percentage of CR, PR, SD patients and and PFS, OS; | — |
Countries
China
Contacts
Public ContactQi Mei
Shanxi Bethune Hospital
Outcome results
None listed