Solid Tumours
Conditions
Interventions
Experimental group:KD6001 Injection
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent; 2. The age at the time of signing the informed consent form is >=18 years and = 3 months; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 5. Patients with advanced solid tumors confirmed by histology or cytology: patients with advanced solid tumors who have failed standard therapy, cannot tolerate standard therapy, refuse/or have no standard therapy (Priority entry for melanoma, kidney cancer, urothelial cancer); 6. At least one measurable lesion as a target lesion (RECIST v1.1 criteria); 7. Agree to provide tumor tissue samples (if possible, provide fresh biopsy samples before treatment, and for patients who cannot provide fresh biopsy samples before treatment, provide archived samples within 2 years); 8. The laboratory test results during the screening period suggest that the subjects have good organ function; 9. Male subjects with reproductive potential or female subjects with the possibility of pregnancy, using effective contraceptive methods (such as oral contraceptives, intrauterine devices or barrier contraceptives combined with spermicides) during the trial, and continue contraception for 6 months after the end of treatment; 10. Good compliance, with follow-up.
Exclusion criteria
Exclusion criteria: 1. History of other malignant tumors other than the research disease in the past 5 years, except for malignant tumors that can be expected to be cured after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery); 2. Received systemic anti-tumor drug therapy, or local anti-tumor therapy, or received clinical investigational drug or device therapy within 4 weeks before the first study drug; 3. Received immunotherapy (including antibody therapy and cell therapy) within 8 weeks before the first study drug; patients who have received CTLA-4 therapy in the past; 4. Adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) grade 1 or below (except for hair loss and neurotoxicity, which cannot be recovered by the investigator's long-term existence); 5. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; suffering from central nervous system metastasis and/or cancerous meningitis. Subjects who have received treatment for brain metastases can be considered for participation in this study; have or are suspected of having active autoimmune disease; have hepatitis and cirrhosis; have clinical symptoms or massive pleural effusion or ascites requiring symptomatic treatment; severe cardiovascular and cerebrovascular disease; pulmonary disease: history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm; active infection requiring systemic treatment; positive human immunodeficiency virus (HIV) antibody test result; active hepatitis B or C; known active tuberculosis (TB); 6. Received systemic corticosteroids (prednisone>10mg/day or equivalent dose) or other immunosuppressive drugs within 14 days before the first study medication; use of broad-spectrum antibiotics that may affect changes in intestinal flora within 14 days before the first study drug; 7. Receive live vaccine within 4 weeks before the first study drug; have undergone major surgical operations within 4 weeks before the first study drug; have a history of psychotropic substance abuse and cannot quit or have a history of mental disorders; pregnancy or lactation; 8. Those who are known to be allergic to KD6001 and its components; 9. There are other serious, acute or chronic medical or psychiatric diseases or laboratory abnormalities that may increase the risks associated with participation in the study, or may interfere with the interpretation of the study results, in the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability;Maximum tolerated dose/recommended extended dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Antitumor activity;Pharmacokinetic characteristics;Immunogenicity; | — |
Countries
China
Contacts
Public ContactCai Zeling
Outcome results
None listed