solid tumors
Conditions
Interventions
Group 1:HF1K16 monotherapy
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide the test of informed consent in writing. 2. Male or female, age > 18 years and 12 weeks. 7. Men or women of childbearing age must agree to adopt effective contraception after signing the informed consent form until 180 days after the end of the study. Premenopausal women or those within 2 years after menopause are included.
Exclusion criteria
Exclusion criteria: 1. Patients received systemic antitumor therapy, including chemotherapy, radiotherapy, biologic therapy, endocrine therapy, or immunotherapy within 3 weeks prior to the first dose, except for the following: Nitrosoureas or mitomycin C within 6 weeks; Oral fluorouracils and small molecule drugs within 2 weeks or within 5 half-life periods of the drug (whichever is longer); Antitumour traditional Chinese medicine within 2 weeks. 2. Adverse effects of previous anti-tumor therapy have not recovered to CTCAE 5.0 grade rating of = grade 1 (except for toxicity judged by the investigator be of no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, etc.) 3. Patients received other unlisted clinical trial drugs or treatments within 28 days prior to the first dose. Cohort 5: In addition to the above provisions, the subject has used bevacizumab or other drugs that act on tumor blood vessels within 3 months before the first drug, including but not limited to: regorafenib, apatinib, Anlotinib and others. 4. Taken vitamin A or any vitamin A derivatives within 7 days prior to the first dose. 5. Past history of deep vein thrombosis or pulmonary embolism. 6. Evidence that there is poor control of thyroid diseases, or diseases of the retina. 7. Patients have symptomatic central nervous system (CNS) metastases, meningeal metastases, or a primary CNS tumor that is associated with progressive neurological symptoms. Except that the brain metastases are shown to be stable judged by imaging examination within 4 weeks. Cohort 5: The above criteria do not apply to the fifth cohort. The fifth cohort allowed inhaled or topical corticosteroids, or hormone therapy at physiological replacement doses due to adrenal insufficiency; short-term (=7 days) corticosteroids were allowed for prophylaxis (eg, contrast media allergy) or treatment of non-autoimmune conditions ( For example, delayed-type hypersensitivity reactions caused by exposure to allergens); systemic corticosteroids (=10 mg/day prednisone, or other equivalent corticosteroids) for 7 consecutive days within 14 days of the first dose are not allowed or Immunosuppressant therapy. 8. Evidences of serious or uncontrolled systemic disease (for example: instability or decompensated respiratory disease, liver or kidney disease) 9. Serious liver and kidney function damage; 10. Has clinical significance of cardiovascular disease, including: ? Left ventricular ejection fraction (LVEF) =50% as shown by echocardiography (ECHO) at baseline. ? Heart failure with a New York Heart Association (NYHA) classification of Class II or higher. ? Poorly controlled hypertension (systolic blood pressure =160 mmHg and/or diastolic blood pressure =95 mmHg despite medication). ? Previous or current cardiomyopathy. 11. Have known immune inhibitory disease or human immunodeficiency virus (HIV) infection. 12. Patients with severe osteoporosis or with bone metastases with serum 25-hydroxyvitamin D assay values less than 50 nmol/L. 13. Active hepatitis (Hepatitis B: HBsAg-positive and HBV-DNA = 500 cps/mL or 200 IU/mLL; HCV RNA-positive). 14. Persons with known hypersensitivity to any of the active ingredients or excipients or a history of atopic allergic reactions. 15. The pregnancy test positive (blood beta human chorionic gonadotropin - HCG [B] test positive) or lactationWomen. 16. Researchers believe that patients with combined disease may affect the compliance. 17. Participants not willing to or fail to follow the procedure. 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limited toxicity;Maximum tolerated dose;Assessing the anti-tumour effect of HF1K16 in recurrent or progressive gliomas of the brain; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics feature;Initial antitumor efficacy;The relationship of HF1K16 exposure and peripheral blood lymphocytes change in subjects;Further evaluation of the safety of HF1K16; | — |
Countries
China
Contacts
Public ContactYongfeng Huang
Hangzhou Highfield Biopharmaceuticals Corporation
Outcome results
None listed