advanced solid tumors
Conditions
Interventions
Treatment group:Iv drip the angiogenesis inhibitory peptide for injection
Sponsors
The First Affiliated Hospital of Bengbu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. ECOG physical condition score is 0~1; 3. Expected survival >= 3 months; 4. Patients with advanced solid tumors diagnosed by histopathology and/or cytology who have failed standard treatment, or have no standard treatment regimen, or are currently not eligible for standard treatment; 5. At least one measurable lesion according to RECIST1.1; 6. Adequate organ function: (1) Blood routine (no blood transfusion or g-CSF treatment within 14 days, ANC >=1.5*10^9/L, PLT >=90*10^9/L, HB >=90 g/L; (2) Liver functionAST/ALT= 60 mL/min; (4) Blood coagulation function INR/PT =50 %,cTnI T <= 1 ULN; 7. The time from the first administration of the drug to the previous anti-tumor therapy (surgery, radiotherapy, chemotherapy, targeted therapy, endocrine therapy or immunotherapy, or other drugs not listed in the clinical trial) is more than 4 weeks (Note: Mitomycin and niturea are at least 6 weeks from the last administrationOral fluorouracil medications such as tecio and capecitabine are at least 2 weeks from the last doseSmall-molecule targeted drugs have at least 2 weeks or at least 5 half-lives from the last administration, whichever is longer Chinese medicine with indications of anti-tumor is at least 2 weeks from the last time of taking medicine); 8. All adverse events with prior systemic anticancer therapy returned to baseline or <= grade 1 (CTCAE 5.0), except for the following: hair lossNeuropathy induced by previous anticancer treatment was stable, <= grade 2; 9. Weight: According to the calculation of "BMI= weight (kg)/height 2 (m2)", BMI should be controlled within the range of 18 to 28; 10. Those who have a full understanding of the purpose and requirements of the trail, can complete the entire test process in accordance with the requirements of the trail, comply with the study regulations, and voluntarily sign the ICF.
Exclusion criteria
Exclusion criteria: 1. Patients with advanced solid tumor with bleeding tendency and vascular invasion; 2. Those who are known to be allergic to angiogenesis inhibitory peptide for injection and any of its components for injection; 3. Major organ surgery (excluding puncture biopsy) or significant trauma occurred within 4 weeks before the first administration; 4. Patients with active or previous autoimmune diseases that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); 5. Third interstitial effusion with clinical symptoms that cannot be controlled by drainage or other methods (such as massive pleural or ascites); 6. A history of interstitial lung disease or interstitial pneumonia, including radiation pneumonia of clinical significance (affecting daily activities or requiring therapeutic intervention); 7. Have a history of serious cardiovascular disease; (1) Ventricular arrhythmias requiring clinical intervention; (2) Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or above cardiovascular events occurred 6 months before enrollment; (3) NYHA cardiac function grade >= GRADE II or LVEF 140mmHg and/or DBP > 90mmHg); 8. Those who have participated in other drug trials or medical device trials within one month before the trial. 9. During the trail period, besides the experimental drug, all other anti-tumor drugs (including proprietary Chinese medicine) are accepted at the same time. 10. Those who have used antiangiogenic drugs before the first administration but have not passed the elution period of 5 half-lives; 11. The patient is receiving chronic systemic steroid therapy, > 10 mg/ day, or any other form of immunosuppressive drug; 12. The patient has uncontrolled active infection; 13. Having a clear history of alcohol or drug abuse; 14. Patients with clinical symptoms of brain metastasis, spinal cord compression, cancerous meningitis, or other evidence that the brain or spinal cord metastasis has not been controlled, are not suitable for inclusion by the researchersPatients with suspected cerebral or pia meningioma should be excluded by CT/MRI examination; 15. The blood pregnancy test results of pregnant or lactating women or women of childbearing age before the study and treatment are positive; 16. Fertile men and women did not use effective contraception or did not agree to continue using effective contraception for at least 3 months after the last study drug was given; 17. A clear history of neurological or psychiatric disorders, including epilepsy or dementia; 18. Patients with active hepatitis B(HBsAg positive and HBV-DNA >= 200IU/ml or 1000 copies /ml)Positive results of HCV-AbTP-AbHIV-Ab; 19. Patients who have a history of other severe systemic diseases and have been determined by the investigator to be unfit to participate in clinical trials; 20. The investigator considers the subject to be unsuitable for inclusion in the study due to any abnormality in clinical or laboratory tests or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety index;AE;MTD;DLT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic index;Pharmacodynamic indicators;Immunogenicity index;ORR;ADA; | — |
Countries
China
Contacts
Public ContactHuan Zhou
The First Affiliated Hospital of Bengbu Medical College
Outcome results
None listed