| Eligibility |
Inclusion Criteria:
1. Age = 18 years old; no gender limitation;
2. Expected survival time =12 weeks;
3. ECOG score is 0 - 1 points;
4. The interval between the first dose of previous anti-tumor therapy and the first dose
must meet the following conditions:
1)Subjects who have received chemical drugs, small molecule targeted therapy drugs,
immunomodulators or Chinese patent medicines with clear anti-tumor indications in the past
should discontinue the drug for at least 2 weeks or 5 half-lives, whichever is shorter;
2)Subjects who have received macromolecular targeted drugs and protein preparations in the
past should discontinue the drug for 5 half-lives or 4 weeks, whichever is shorter;
3)Subjects who have previously received radiotherapy, cell transplantation, CAR-T or immune
checkpoint inhibitors such as PD-1/PD-L1 therapy should discontinue the drug for at least 4
weeks; 5. Subjects who have suitable organ function and hematopoietic function:
1. Neutrophil count =1.0 × 109/L; (no short-acting drugs for leucopenia within 1 week; no
long-acting drugs for leucopenia within 3 weeks, such as granulocyte
colony-stimulating factor);
2. Platelet count =75 × 109/L (without bone marrow infiltration) / =50 × 109/L (with bone
marrow infiltration); (have not received platelet transfusion therapy within 1 week);
3. Hemoglobin =80 g/L (without bone marrow infiltration) / =70 g/L (with bone marrow
infiltration); (have not received red blood cell transfusion therapy or biological
response modifiers such as erythropoietin within 2 weeks);
4. Total bilirubin (TBIL) = 1.5 × ULN; TBIL = 3 × ULN if there is liver metastasis;
5. Both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be
=2.5×ULN; if there is liver metastasis, both AST and ALT should be =5.0×ULN;
6. International normalized ratio (INR) = 2 × ULN, or activated partial thromboplastin
time (APTT) = 2.0 × ULN;
7. Heart: left ventricular ejection fraction (LVEF) = 50%;
8. Creatinine clearance (CrCl) =30 mL/min/1.73m2 or serum creatinine (Cr) =1.5 × ULN; 6.
Subjects who have AEs related to previous systemic chemotherapy, radical/extensive
radiotherapy or other anti-tumor drug treatment recovered to (NCI CTCAE v5.0) = grade
1 (except for alopecia, skin hyperpigmentation, skin induration, skin atrophy, which
are not clinically significant or those with no clinical significance in the opinion
of the investigator); 7. Men and women of childbearing age should agree to take
effective contraceptive measures such as barrier contraception, hormonal contraception
or long-term use of contraceptives from the time of signing the informed consent to 3
months after the last dose.
8. Subjects should voluntarily sign the informed consent form, understand the study and be
willing to follow the protocol requirements and have the ability to complete all
experimental procedures.
9. Subjects' diseases can be assessed.
Exclusion Criteria:
1. Subjects have received CD70-targeted therapy in the past; 2. Subjects who have received
allogeneic transplantation in the past and require continuous use of immunosuppressive
agents; 3. Patients who have primary central nervous system (CNS) malignant tumor or
patients with active CNS metastases who have failed local treatment (radiotherapy or
surgery), but the following patients are allowed to be enrolled: a. asymptomatic brain
metastases; b. clinically stable (i.e. no imaging progression was seen 4 weeks before the
first dose, and any neurological symptoms had returned to baseline levels) and no treatment
for brain metastases was required; 4. Subjects who have serious organic disease, or the
investigator judges that it is not suitable to participate in the study due to the
combination of other serious diseases:
1. Have hypertension, pulmonary hypertension, or unstable angina that is difficult to
control with medication;
2. Have myocardial infarction or bypass or stent surgery within 6 months before
administration;
3. History of chronic heart failure with New York Heart Association (NYHA) criteria 3-4
within 6 months prior to administration;
4. Have serious arrhythmias requiring treatment (excluding atrial fibrillation,
polymorphic ventricular tachycardia), including QTc =450ms for men and =470ms for
women (calculated by Fridericia formula);
5. Have cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 12
months before enrollment;
6. History of arterial thrombosis, deep vein thrombosis and pulmonary embolism within 3
months before administration;
7. History of moderate or severe dyspnea at rest, or current need for continuous oxygen
therapy, or current interstitial lung disease (ILD) or pneumonia, severe chronic
obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic
bronchospasm;
8. Presence of a disorder that may cause gastrointestinal bleeding or perforation (e.g.
symptomatic duodenal ulcer requiring treatment, intestinal obstruction, acute or
chronic Crohn's disease, ulcerative colitis, or those with a history of intestinal
perforation and intestinal fistula who have not been cured);
9. The puncture and drainage treatment cannot control the disease and repeated drainage
is required or there is pleural, abdominal or pericardial effusion with obvious
symptoms; 5. Subjects who have active viral hepatitis B (HBsAg positive and/or HBcAb
positive, and HBV DNA =1000 IU/mL), or active viral hepatitis C (anti-HCV antibody
positive, and HCV RNA higher than the lower limit), or who are HIV-infected.
6. Subjects who have active autoimmune disorders and need to rely on immunosuppressive
therapy or receive systemic hormone therapy with a dose of =10 mg/day of prednisone or
other equivalent hormones within 2 weeks before enrollment; 7. Subjects who have
uncontrollable serious active infection (such as sepsis, bacteremia, viremia, etc.); 8.
Subjects who have received live attenuated vaccine within 4 weeks before the first
administration; 9. Subjects who have major surgery within 4 weeks before the first
administration or plan to take major surgery within 3 months after the first administration
of the study drug, excluding intubation, peripheral venipuncture, central venous
catheterization, etc.; 10. Subjects who have a history of neurological or mental disorders
and have been hospitalized within the past six months, and have a history of alcohol and
drug abuse within the past year; 11. Women with positive serum pregnancy test or during the
lactation period; 12. Men and women of childbearing age are unwilling to take adequate
contraceptive measures during the study period and within 3 months after the last dose; 13.
Other circumstances that the investigator considers inappropriate to participate in this
study.
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