Advanced solid tumors
Conditions
Interventions
Trial group 1:Drug name: rHSV-1-APD1
Dose: 4×10^7 PFU
Usage: intravenous infusion
Trial group 2:Drug name: rHSV-1-APD1
Dose: 1×10^8 PFU
Usage: intravenous infusion
Trial group 3:Drug name: rHSV-1-APD1
Dose: 4×10^8 PFU
Usage: intravenous infusion
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >=18 years; 2.Patients with advanced malignant solid tumors confirmed by histology or cytology (primary liver cancer [diffuse type, non-giant tumor, giant tumor debulking surgery], colorectal cancer, non-squamous non-small cell lung cancer are preferred), standard treatment fails, or there is no standard treatment plan, or the current stage is not suitable for standard treatment; 3.At least one measurable tumor lesion that meets the RECIST V1.1 criteria; 4.ECOG physical fitness score 0-1 points; 5.Expected survival time >= 3 months; 6.Adequate organ function: 7.Serum HSV-1 antibody IgG positive (only applicable to the esclating stage); 8.Fertile subjects (male and female) must agree to use medically approved contraception with their partner during the study and for at least 90 days after the last dose; fertile female subjects within 7 days prior to enrollment. Blood pregnancy test must be negative; 9.Voluntary signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of any other malignancies within 5 years (other than basal cell carcinoma of the skin, carcinoma in situ of the cervix, other malignancies that have been effectively controlled without treatment in the past 5 years, and double primary tumors that the investigator believes could benefit from the clinical trial); 2. Patients with clinical symptoms of central nervous system metastasis or meningeal metastasis, or other evidence that the central nervous system metastasis or meningeal metastasis has not been controlled, and the investigators judged that they were not suitable for inclusion; 3. In the stage of recurrent herpes simplex virus infection, and there are corresponding clinical manifestations (such as oral herpes, herpetic keratitis, herpetic dermatitis, genital herpes, etc.), or need anti-HSV treatment; 4. There are other active infected persons; 5. Active hepatitis B, HBsAg positive and HBV DNA>2000 IU/ml; Active hepatitis C, positive for antibodies and positive for HCV RNA; 6. Uncontrolled pleural effusion, pericardial effusion, or frequent ascites extraction; 7. Impaired cardiac function or clinically significant cardiovascular and cerebrovascular diseases, including but not limited to: a) Have severe cardiac rhythm or conduction abnormalities, such as severe uncontrolled arrhythmias requiring medical treatment, QTc interval =480ms, etc.; b) A history of myocardial infarction or bypass surgery, stent surgery, congestive heart failure, or unstable angina pectoris within 6 months prior to initial administration; c) New York Heart Association (NYHA) heart function grade =? or left ventricular ejection fraction (LVEF) 10mg/ day or equivalent dose of the same drug) or other immunosuppressant therapy within 14 days prior to the first use of the study drug; The following are excluded: treatment with local, ocular, intraarticular, intranasal, and inhaled corticosteroids; Short-term use of glucocorticoids for preventive treatment (e.g. to prevent hypersensitivity to contrast media); 14. Use of immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc. within 14 days prior to the first use of the investigational drug; 15. Patients who require an injection of live or attenuated vaccine within 28 days prior to administration of the initial study drug and during the expected study period; 16. Have used
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| rHSV-1-APD1 copy number;Cytokine;PD-1 antibody;Anti-drug antibody;HSV-1 neutralizing antibody; | — |
Countries
China
Contacts
Public ContactZhang Jian
Affiliated Cancer Hospital of Fudan University
Outcome results
None listed