Advanced solid tumor
Conditions
Interventions
The first stage (dose escalation stage): experimental group:KLT-1101
The second stage (dose expansion stage): experimental group:KLT-1101
The second stage (dose expansion stage): control group:PEG-rhG-CSF
The second stage (dose expansion stage): control group:KLT-1101+PEG-rhG-CSF
The third stage (the clinical recommended dose test stage): experimental group :KLT-1101
Sponsors
The First Affiliated Hospital of Bengbu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Dose escalation stage 1) Volunteer to participate in this clinical trial, have the ability to understand the research requirements, and sign a written informed consent; 2) Aged 18 to 75 years old, male or female (including 18 years old and 75 years old); 3) KPS score> 70 points; 4) It is diagnosed as advanced solid tumor by imaging and histology or cytology; 5) Have at least one measurable lesion according to the RECIST 1.1 standard; 6) Chemotherapy is needed; 7) Estimated survival time >=12 weeks; 8) Good organ function level (no blood transfusion, no use of G-CSF, no other blood-boosting drugs within 7 days before screening; no ALB transfusion within 7 days); ANC >=1.5x10^9/L; WBC>=3x10^9/L; PLT>=90x10^9/L; Hb>=90g/L; International Normalized Ratio (INR) =29g/L; TBIL 70 points; 4) It is diagnosed as advanced triple-negative breast cancer by imaging and histology or cytology; 5) Immunohistochemical diagnosis of PR-, ER-, HER-2-, such as PR-, ER- but Her-2 (+) or (++) can choose FISH to detect Her-2 gene amplification negative; 6) Have at least one measurable lesion according to the RECIST 1.1 standard; 7) Advanced triple-negative breast cancer patients who are newly treated or retreated, or need adjuvant chemotherapy or neoadjuvant chemotherapy, and are suitable for chemotherapy with docetaxel + adriamycin + cyclophosphamide (TAC) regimen; 8) Estimated survival time >=12 weeks; 9) Good organ function level (no blood transfusion, no use of G-CSF, no other blood raising drugs within 7 days before screening; no ALB transfusion within 7 days) ANC>=1.5x10^9/L; WBC>=3x10^9/L; PLT>=90x10^9/L; Hb>=90g/L; International Normalized Ratio (INR) =29g/L; TBIL<=1.5 ULN; Cr<=1.5 ULN; Urine routine shows urine protein <2+; 10) Agree to take effective contraceptive measures (including but not limited to: contraception with tools, surgery, abstinence, etc.) during the entire study period, until at least 6 months after the last study administration; (3) Clinical recommended dose test phase 1) According to the test results of the dose escalation and dose expansion phases and other data and research results, select and determine the tumor type and the criteria for inclusion and discharge, and enroll 24 subjects.
Exclusion criteria
Exclusion criteria: 1. The toxicity of the previous treatment plan has not recovered before enrollment, and there are still toxic reactions above grade 2 (except for hair loss); 2. Patients with known or suspected brain metastases, including central nervous system and spinal cord compression or meningeal metastases (except for those with stable disease who can be included in the group as judged by the investigator); 3. Active infections requiring systemic treatment; 4. Untreated active hepatitis B. (Note: Except for hepatitis B subjects who meet the following criteria: (1) The hepatitis B virus (HBV) load must be less than 1000 copies/ml (200IU/ml) or lower than the lower limit of detection before the first administration; (2) For anti-HBc (+ ), HBsAg (-), anti-HBs (-) and HBV viral load (-) subjects do not need to receive preventive anti-HBV treatment, but need to closely monitor virus reactivation); 5. Subjects with active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA level higher than the lower limit of detection); 6. A known history of immunodeficiency virus (HIV) infection (ie HIV1/2 antibody positive), or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 7. Known severe cardiovascular disease, myocardial infarction, or arterial thrombosis, or unstable angina, or known heart failure in the past 6 months; 8. Severe hypertension and diabetes are known (except for those patients who are stable and can be included in the group as judged by the investigator); 9. There is a history of severe venous thrombosis or pulmonary embolism (except for patients who are stable and can be included in the group as judged by the investigator); 10. There is a third space effusion that cannot be controlled by drainage or other methods (such as a large amount of pleural fluid and ascites); 11. Severe coagulation abnormality, bleeding tendency or receiving thrombolysis or anticoagulation therapy; 12. Patients who have undergone major surgery (if general anesthesia is required), open biopsy, severe traumatic injury, unhealed wound or have not recovered from major surgery within 4 weeks before enrollment. 13. CYP3A4 strong inducers, strong inhibitors and sensitive substrates of CYP3A4/2D6 were used within two weeks before the start of treatment; 14. Received CD137 agonist, anti-PD-1 or anti-PD-L1 therapeutic antibody (and other immunotherapy) or immune checkpoint targeted drug therapy within 6 months before the start of treatment; 15. Those who have participated in clinical trials of other drugs or medical devices within 1 month before screening, or plan to participate in any other clinical trials during the study period; 16. A history of alcohol, drug or drug abuse within the past year; 17. Those who have a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance; 18. Patients who have a positive blood pregnancy test result during pregnancy or lactation or women of childbearing age (and the pregnancy cannot be ruled out by ultrasound); 19. Those who are known to be allergic to the test drug or its components; have a history of hypersensitivity to paclitaxel or other drugs that are the same as the solvent used (polyoxyethylene castor oil); 20. Patients who were vaccinated within 4 weeks before screening or planned to be vaccinated during the study period; 21. The investigator believes that it can cause harm to the study drug or cause basic diseas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic index;Blood indicators;Biomarkers;Immunogenicity index;Objective response rate;Progression-free survival; | — |
Countries
China
Contacts
Public ContactHuan Zhou
The First Affiliated Hospital of Bengbu Medical College
Outcome results
None listed