Solid tumor
Conditions
Interventions
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, male or female; 2. Histologically or pathologically confirmed recurrent or metastatic solid tumor; 3. Failure of prior standard systemic therapy, or intolerance due to severe toxicity, or absence of an available standard treatment; 4. At least one measurable lesion according to RECIST v1.1; 5. At least one tumor lesion with a longest diameter of =1 cm that is amenable to biopsy and intratumoral injection under ultrasound or CT guidance. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0–1; 7. Expected survival of at least 3 months; 8. Adequate major organ function, with laboratory parameters meeting the following requirements: (1) Hematology: white blood cell count >=3.0 × 10^9/L; absolute neutrophil count >=1.0 × 10^9/L; hemoglobin >=80 g/L; platelet count >=90 × 10^9/L. (2) Blood chemistry: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3.0 × the upper limit of normal (ULN); total bilirubin <=3.0 × ULN; serum creatinine <=1.5 × ULN. Abnormal hematology or biochemistry values may be managed with symptomatic/supportive treatment during the screening period at the investigator’s discretion. (3) Coagulation function: prothrombin time (PT) and activated partial thromboplastin time (APTT) <=1.5 × ULN; 9. Women of childbearing potential must agree to use contraception during the study and for 3 months after study completion, and must have a negative serum pregnancy test at screening; male participants must agree to use contraception during the study and for 3 months after study completion; 10. The participant is able to understand and comply with the study procedures and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Clinically symptomatic central nervous system metastases or leptomeningeal metastases; 2. Active infection, including: (1) Positive hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody (anti-HCV), with HBV DNA or HCV RNA above the lower limit of detection during the screening period; (2) Known history of HIV infection or positive HIV antibody test during screening; (3) Known history of tuberculosis infection; (4) Any other active infection requiring treatment with antibiotics, antifungal agents, or antiviral agents, as judged by the investigator; 3. Severe or uncontrolled underlying diseases identified during screening, as judged by the investigator, such as hypertension, diabetes mellitus, cardiovascular or cerebrovascular disease, pulmonary disease, or autoimmune disease; 4. Persistent adverse reactions from prior anticancer therapy that, in the investigator’s opinion, may affect the safety assessment of the investigational product; 5. Prior treatment with an investigational product delivered via an adenoviral vector; 6. Receipt of anticancer therapy within 28 days prior to the first investigational product injection, or within 5 half-lives, whichever is shorter; 7. Receipt of surgery or radiotherapy requiring general anesthesia within 28 days prior to the first investigational product injection, excluding local radiotherapy for pain palliation; 8. Receipt of a live vaccine or attenuated live vaccine within 28 days prior to the first investigational product injection; 9. Known allergy or hypersensitivity to any component of the investigational product; 10. Presence of serous cavity effusion requiring clinical intervention; 11. Pregnant or breastfeeding women, or subjects who intend to become pregnant during the clinical trial period; 12. Any other condition that, in the opinion of the investigator, renders the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicities (DLTs);Incidence of adverse events (AEs), treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs); ;Abnormal findings and changes from baseline in physical examinations and laboratory assessments (including complete blood count, blood biochemistry, urinalysis, coagulation function, electrocardiography, etc.).; | — |
Secondary
| Measure | Time frame |
|---|---|
| RDR1 protein/mRNA expression levels (peripheral blood and tumor tissue);;Objective response rate (ORR) and disease control rate (DCR);Duration of response (DOR);Progression-free survival (PFS);Overall survival (OS);Plasma exosomal miRNAs (peripheral blood);Cytokines such as IL-2, IL-6, IFN-?, and TNF-a (peripheral blood);Other immune-related biomarkers at the gene/transcriptome/protein level (tumor tissue);Viral load and shedding (peripheral blood and urine);Anti-adenoviral antibodies (peripheral blood); | — |
Countries
China
Contacts
Public ContactNing Li
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed