malignant solid tumor
Conditions
Interventions
Experimental group1:Dosage of the study drug during week 1-4: 0.05 µg/kg A-337
Experimental group2:Dosage of the study drug during week 1-2: 0.05 µg/kg A-337. Dosage of the study drug during week 3-4: 0.15 µg/kg A-337
Experimental group3:Dosage of the study drug during week 1-2: 0.05 µg/kg A-337. Dosage of the study drug during week 3-4: 0.3 µg/kg A-337
Experimental group4:Dosage of the study drug during week 1-2: 0.05 µg/kg A-337. Dosage of the study drug during week 3-4: 0.6 µg/kg A-337
Experimental group5:Dosage of the study drug during week 1-2: 0.05 µg/kg A-337. Dosage of the study drug during week 3-4 is: 0.9 µg/kg A-337
Experimental group6:Dosage of the study drug during week 1-2: 0.05 µg/kg A-337. Dosage of the study drug during week 3-4 is: 1.2 µg/kg A-337
Experimental group7:Dosage of the study drug during week 1-2: 0.05 µg/kg A-337. Dosage of the study drug during week 3-4 is: 1.5 µg/kg A-337
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old, regardless of gender; 2. Histologically or cytology confirmed advanced malignant solid tumors, standard treatment failure, or no standard treatment plan, or standard treatment is not applicable at this stage; 3. At least 28 days before the first study drug administration should be separated from previous major surgery, medical device treatment or local radiotherapy; at least 21 days between prior cytotoxic chemotherapy, immunotherapy, and biologic therapy; at least 14 days between prior tumor-related endocrine therapy and minor surgery; The interval between small molecule targeted drugs is at least 21 days or 5 half-lives, whichever is longer; Chinese medicines with anti-tumor indications have an interval of at least 14 days; 4. Have at least one evaluable lesion as defined in RECIST criterion v1.1; 5. Eastern Cancer Collaborative Group (ECOG) physical condition score <= 1 point; 6. Willing to provide archived tumor tissue or receive fresh tissue biopsy; 7. Life expectancy of at least 3 months; 8. Have adequate organ and bone marrow functional reserves; 9. Subject is able to sign informed consent and is able to comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Previous or current other types of malignancy diagnosed and/or requiring treatment within the past 3 years, except in the following cases: completely resected basal cell and squamous cell skin cancer, completely resected carcinoma in situ of any type; 2. Subjects with known central nervous system (CNS) metastases, unless the metastases have been treated and stabilized for at least 4 weeks and the subject is not taking systemic steroids >= 10 mg prednisone/day or equivalent; 3. Suspected or confirmed immunocompromised; 4. Use of anticancer therapy, including hormonal therapy, biological therapy, cell therapy, or radiotherapy, within 4 weeks prior to the start of study treatment, except in the following cases: (1) Hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists for prostate cancer; (2) Hormone replacement therapy or oral contraceptives; 5. The investigator determines that the subject has a disease, medical condition or social factor that may affect the results of the study or compliance, and the program stipulates that the following conditions cannot participate in this study: (1) Uncontrolled acute infection or confirmed bacteremia; (2) Known human immunodeficiency virus (HIV) infection or active hepatitis B or chronic hepatitis B virus (HBV) infection, and HBV copy number > 1000/mL or HBV DNA titer > 200 IU/mL; People with active hepatitis C virus (HCV) infection; (3) Severe dyspnea, pulmonary insufficiency, or continuous oxygen; (4) New York Heart Association (NYHA) grade of cardiac insufficiency as grade 3 or 4 or left ventricular ejection fraction (LVEF) 180 mmHg and diastolic blood pressure > 100 mmHg) or diabetes mellitus; 6. Uncontrolled systemic infection; 7. Clinically significant C-reactive protein elevation by the investigator; 8. Treponema pallidum antibody positive; 9. Patients who have undergone major surgical procedures (craniotomy, thoracotomy, or laparotomy) or have unhealed wounds, ulcers or fractures within 4 weeks prior to the first dose of study drug administration, except for needle biopsy surgery; 10. Known alcohol or drug dependence; 11. People with mental disorders, including epilepsy or dementia, or poor compliance; 12. Patients with tumors of non-epithelial origin; 13. Patients who have previously received EpCAM antibody, CD3 double antibody or CAR-T therapy; 14. Adverse reactions caused by previous anti-tumor therapy have not been restored to CTCAE 5.0 level evaluation= grade 1 toxicity (except hair loss); After radiotherapy, radiotoxicity did not return to CTCAE 5.0 level evaluation level 1 and below (except for not affected); 15. Women of childbearing age who are pregnant (positive pregnancy test), lactating, and who do not agree to use contraception for at least 3 months from the signing of the informed consent form to the end of the study; Within 7 days before day 1 of treatment, women of childbearing age tested positive for a pregnancy test (HCG); 16. Male subjects (other than surgical sterilization) who did not consent to contraceptive use for at least 3 months from the signing of the informed consent form to the end of the study; 17. Known allergy to the study drug or its excipients; 18. Subjects deemed unsuitable by the investig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence and characteristics of adverse events;Dose limited toxicities;Maximum tolerated dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak concentration;Pharmacodynamic indicators;Objective response rate;Pharmacokinetic (PK) evaluation indicators; | — |
Countries
China
Contacts
Public ContactZhou Qinghua
West China Hospital of Sichuan University
Outcome results
None listed