Advanced solid tumor
Conditions
Interventions
treatment group:Intravenous injection of HS636
Sponsors
The First Affiliated Hospital of Zhejiang University Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical research; fully understand, know the research and sign ICF; willing to follow and have the ability to complete all test procedures; 2. Age: >= 18 years old (subject to the day of signing the informed consent), both male and female; 3. The enrolled subjects must have advanced or metastatic tumors (unable to be removed) confirmed by histology or cytology (only limited to cell wax blocks), and the standard treatment fails, there is no standard treatment or the subjects refuse the standard treatment; 4. The score of ECoG in the eastern tumor cooperative group was 0 or 1; 5. According to RECIST v1.1 (solid tumor) or Lugano 2014 standard (lymphoma), subjects had at least one measurable focus [bone metastasis only or CNS metastasis only as measurable focus is not accepted]; 6. Expected life span of at least 3 months; 7. If the subjects have received anti-tumor treatment in the past, they should not be enrolled until the toxicity of the previous treatment has returned to the baseline level (except for the residual hair loss effect) or the score of CTCAE v4.03 = 1.5 x 10^9 / L; platelet count (PLT) >= 100 x 10^9 / L; hemoglobin content (Hgb) >= 9.0 g / dl (WBC >= 3.05 x 10^9 / L; PLT >= 70 x 10^9 / L). (2) liver function: TBIL = 50ml / min, urinary protein = 2 + at baseline, 24-hour urine collection should be carried out and the protein content in urine within 24 hours < 1g; (4) blood function: APTT and INR <= 1.5 ULN; (5) normal or abnormal thyroid function has no clinical significance; 9. Pregnancy test must be negative when female subjects of childbearing age enter the study; female subjects of childbearing age or male subjects and their partners should agree to take effective contraceptive measures within 6 months from signing ICF to using the last study drug.
Exclusion criteria
Exclusion criteria: 1. Patients with meningeal metastasis or central nervous system metastasis with clinical symptoms are known; 2. There is any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, which can be included in adult without any intervention; subjects need bronchus Asthmatic patients who received medical intervention with dilators were not included; 3. Patients with known history of primary immunodeficiency; 4. Patients with bleeding tendency or undergoing thrombolysis or anticoagulation treatment; 5. Subjects who need to be treated with glucocorticoids (prednisone > 10 mg / day or equivalent dose of other similar drugs) or other immunosuppressants due to certain conditions within 14 days before randomization; 6. Major operation, radical radiotherapy, palliative radiotherapy or therapeutic radiopharmaceuticals were performed within 28 days before randomization; 7. Received systemic anti-tumor treatment 14 days before randomization, including chemotherapy, immunotherapy, biotherapy (tumor vaccine, cytokines, or growth factors controlling cancer), etc.; 8. Chinese herbal pieces or proprietary Chinese medicine that have received anti-tumor treatment within 7 days before randomization; 9. Have suffered from interstitial lung disease, chemical pneumonia, allergic pneumonia, connective tissue disease pneumonia, pulmonary fibrosis, acute lung disease, etc. (except for local interstitial pneumonia induced by radiotherapy); 10. Any one of the human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody and hepatitis C virus antibody (HCV AB) positive should be excluded. Or HBsAg is positive (if HBsAg is negative, HBcAb is positive, and HBsAb is negative, HBV DNA needs to be determined, and if DNA exceeds the upper limit of normal detection, it needs to be excluded); 11. Have a history of active tuberculosis or tuberculosis; 12. Any active infection requiring systemic treatment by intravenous infusion occurred within 14 days before randomization; 13. Inoculated or planned to receive live / attenuated vaccine within 28 days before enrollment; 14. Have received the history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 15. Patients who have received any antibody / drug (including anti programmed death factor-1 (PD-1), PD-L1, etc.) targeting T cell co regulatory protein (immunocheckpoint); 16. Those who had received immunotherapy and had the level of immune related AE >= 3; 17. Patients with known severe allergic reaction to MAb (CTCAE v4.03 grade > 3 grade), and patient. swith uncontrolled history of allergic asthma; 18. Pregnant or lactating women; 19. Persons with a known history of alcohol or drug abuse; 20. Patients with major cardiovascular diseases (such as congestive heart failure, unstable angina, atrial fibrillation, arrhythmia, etc.); 21. With a history of mental illness; 22. At present, patients with diseases affecting intravenous injection and venous blood collection; 23. Patients with any other malignancies in the past 5 years, excluding completely cured cervical carcinoma in situ, basal cell or squamous cell skin cancer; 24. According to the judgment of the investigator, the basic condition of the su
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerance of hs636 single drug in patients with advanced cancer;Pharmacokinetics of hs636 single drug in patients with advanced cancer;Immunogenicity of hs636 single drug in patients with advanced cancer;Antitumor activity (ORR, DCR, PFS) of hs636 single drug in patients with advanced cancer; | — |
Countries
China
Contacts
Public ContactZhou Jianying
the First Affiliated Hospital of Zhejiang University Medical College
Outcome results
None listed