EpCAM positive advanced malignant solid tumors (such as liver cancer, colorectal cancer, breast cancer, etc.)
Conditions
Interventions
Test group:PMC2129G12 mRNA-LNP Injection
Sponsors
Gansu Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in the clinical study, understand the study procedures and are able to sign an informed consent form (ICF) in person. 2. Age at the time of signing ICF: 18~75 years old (including both ends), gender is not limited. 3. Patients with recurrent/metastatic advanced solid tumors confirmed by tissue or cytology, who have failed or are intolerant of standard clinical treatment or lack of standard treatment options. 4. EpCAM expression was confirmed by immunohistochemistry. 5. Measurable tumor lesions according to RECIST 1.1 criteria. 6. ECOG PS score: 0-1 points. 7. Expected survival time>= 3 months. 8. Have sufficient bone marrow, liver, kidney, metabolic and coagulation functions, and the functional level of organs within 7 days before dosing meets the following requirements (no blood transfusion, no use of hematopoietic stimulating factors, no use of albumin or blood products within 14 days before examination): Platelet count (PLT) >= 100×10^9/L, absolute neutrophil value (NEUT) >= 1.5×10^9/L, hemoglobin (Hb) >= 90 g/L or >= 5.6 mmol/L; Total bilirubin (TBIL) = 50 ml/min (calculated using the Cockcroft-Gault formula); Albumin >= 28g/L (albumin infusion is not allowed within 14 days before the first dose) The international normalized ratio (INR), activated partial thromboplastin time (APTT) and prothrombin time (PT) were all <= 1.5 × ULN. 9. Female subjects of childbearing potential should agree to use contraception (such as intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after the end of the study, have a negative serum pregnancy test within 7 days prior to dosing, and must be non-lactating subjects; Male subjects (female partners of childbearing potential) must use effective contraception during the study and for 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1. Previous use of EpCAM or CD3 target-related therapy. 2. Received anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, taking anti-tumor active Chinese medicine, etc.) within 5 half-lives or within 21 days (whichever is longer) before the first use of the investigational drug; or participate in other clinical trials and have received clinical trial drugs for less than 4 weeks. 3. Active autoimmune disease requiring systemic therapy within 2 years prior to initiation of study treatment, or in the judgment of the investigator with an autoimmune disease that may relapse or is planned for treatment, including but not limited to inflammatory bowel disease, celiac disease, Wegener syndrome, Hashimoto's thyroiditis, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, except for the following: (1) Type I diabetes mellitus or hypothyroidism requiring only a stable dose of hormone replacement therapy; (2) hypothyroidism caused by Hashimoto's thyroiditis requiring only stable doses of hormone replacement therapy; (3) Skin diseases that do not require systemic treatment (e.g. vitiligo, alopecia, psoriasis or eczema); (4) Childhood asthma has been completely relieved and no intervention is required in adulthood; (5) The investigator judges that the disease will not recur in the absence of external triggers. 4. Subjects requiring systemic treatment with glucocorticoids (>10mg/day prednisone or equivalent) or other immunosuppressive drugs within 14 days prior to the first dose, with the following exceptions: (1) If there is no active autoimmune disease, inhaled, ophthalmic, intra-articular or topical glucocorticoids are allowed; (2) Physiological doses of systemic glucocorticoids 450 ms for males and 470 ms for females>; b) Complete left bundle branch block, second- or third-degree atrioventricular block; c) severe, uncontrolled cardiac arrhythmias requiring medication; d) New York College of Cardiology (NYHA) > Class 2 heart failure; e) Left ventricular ejection fraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody concentration;Objective response rate;Disease control rate,;Duration of response; | — |
Countries
China
Contacts
Public ContactYu Miao
Gansu Provincial Hospital
Outcome results
None listed