EGFR positive Advanced Solid tumors
Conditions
Interventions
medication administration team:CMDE005 for injection
Sponsors
The first affiliated hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Has fully understood and voluntarily signed an informed consent form for this study and is willing and able to comply with study procedures. 2.Age = 18 years. 3.Weight = 30 kg. 4.(Applicable to Part A) Histopathological diagnosis confirmed unresectable EGFR-positive advanced solid tumors that have failed or are intolerant to standard systemic treatment, or for which effective standard treatment is currently unavailable (specific tumor types prioritized in Part B). Subjects who refuse or are unsuitable for standard treatment will be allowed to enroll, but this must be documented in the medical record. 5.(Applicable to Part B) Histopathological diagnosis confirmed unresectable target tumor types that have failed or are intolerant to standard systemic treatment, or for which effective standard treatment is currently unavailable. Subjects who refuse or are unsuitable for standard treatment will be allowed to enroll, but this must be documented in the medical record. Target tumor types include: EGFR-positive pancreatic cancer, EGFR-positive non-small cell lung cancer, EGFR-positive esophageal squamous cell carcinoma, EGFR-positive urothelial carcinoma, EGFR-positive renal cell carcinoma, and other tumor types. 6.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 7.Expected survival = 3 months. 8.At least one measurable lesion via RECIST v1.1 criteria with unequivocal imaging progression of the target lesion without or after prior radiation therapy. 9.Adequate organ function as detailed for full laboratory tests required for enrolled subjects (no blood components, cell growth factors, albumin, or other corrective therapeutic agents are allowed within 14 days prior to obtaining laboratory tests): Hematologic (no transfusion or hematopoietic stimulating factor treatment within 14 days) Absolute Neutrophil Count (ANC) = 1.0 × 10^9/L Platelet Count (PLT) = 90 × 10^9/L Hemoglobin (Hb) = 90 g/L Hepatic function Total Bilirubin (TBIL) = 1.5 × ULN(Gilbert's syndrome or liver metastasis/hepatocellular carcinoma subjects = 3.0 × ULN) Alanine Aminotransferase (ALT) = 2.5 × ULN; for liver metastasis/hepatocellular carcinoma subjects: = 5.0 × ULN Aspartate Aminotransferase (AST) = 2.5 × ULN; for liver metastasis/hepatocellular carcinoma subjects: = 5.0 × ULN Albumin = 3.0 g/dL Renal Function Creatinine = 1.5 × ULN; or Creatinine Clearance (Ccr) = 50 ml/min (calculated using the Cockcroft-Gault formula, only if creatinine > 1.5 × ULN) Urinary Protein = 2+ Coagulation Function Activated Partial Thromboplastin Time (aPTT) = 1.5 × ULN International Normalized Ratio (INR) and Prothrombin Time (PT) = 1.5 × ULN 10.Female subjects had evidence of postmenopausal status or a negative serum pregnancy test result for premenopausal female subjects. Women who have been amenorrheic for 12 months without other medical reasons are considered postmenopausal. Specific requirements for age are as follows: Female subjects < 50 years of age may be considered postmenopausal if they have been amenorrheic for 12 months or more following discontinuation of exogenous hormone therapy and have luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range or have undergone surgical sterilization (bilateral oophorectomy or hysterectomy). Female subjects = 50 years of age may be considered postmenopausal if they have been amenorrheic for 12 months or more following discontinuation of all exogenous hormone therapy, or had radiation induced oo
Exclusion criteria
Exclusion criteria: 1.Used any other clinical trial investigational drug within 4 weeks prior to the first dose of the study drug. 2.Previously received CAR-T cell therapy. 3.At least 2 weeks must have elapsed between the last dose of radiotherapy and the first study intervention, and any acute toxicity from prior radiotherapy must have recovered to = Grade 1. 4.At least 3 weeks must have elapsed since the last dose of systemic chemotherapy (6 weeks if the chemotherapeutic agent is a nitrosourea or mitomycin C; 2 weeks for oral fluorouracil); at least 3 weeks since the last dose of monoclonal antibody therapy (including immune checkpoint inhibitors such as PD-1, PD-L1, CTLA-4, etc.); at least 2 weeks since the last dose of small molecule targeted therapy; at least 3 weeks since the last dose of antibody-drug conjugate (ADC) therapy; at least 2 weeks since the last dose of traditional Chinese medicine with anti-tumor indications. 5.Previous treatment interruption due to severe and/or life-threatening immune-related toxicities. 6.Adverse reactions due to prior anticancer therapy have not recovered to grade = 1 by NCI-CTCAE v5.0 prior to enrollment (except alopecia or tolerable events due to anticancer therapy as judged by the investigator). 7.History of other primary malignancies within the past 5 years, except for patients who underwent curative treatment and have had no disease recurrence in the past 5 years for basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma. 8.Symptomatic or active progressive central nervous system (CNS) metastases and/or carcinomatous meningitis. 9.Underwent major organ surgery within 4 weeks prior to the first dose of the study drug (excluding puncture biopsy and well-recovered minimally invasive surgeries) or experienced significant trauma, or requires elective surgery during the trial. 10.Presence of active autoimmune diseases at screening, including but not limited to immune-related myocarditis, immune-related pneumonia, myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, vasculitis, or glomerulonephritis. 11.Received systemic corticosteroids (prednisone >10 mg/day or equivalent) or other immunosuppressants within 7 days prior to the first dose of the study drug. 12.Received traditional Chinese medicine decoctions or preparations with anti-tumor indications within 2 weeks prior to the first dose of the study drug. 13.History of allogeneic/autologous hematopoietic stem cell transplantation or solid organ transplantation. 14.Received live virus vaccinations within 4 weeks prior to the first dose of the study drug. 15.Concurrent severe medical illnesses, including severe cardiac diseases (e.g., pulmonary hypertension or unstable angina, history of myocardial infarction or coronary artery bypass surgery or stenting within 6 months prior to the first dose, NYHA class 3-4 chronic heart failure, clinically significant valvular disease, LVEF 480 ms), cerebrovascular diseases (history of stroke or transient ischemic attack within 6 months prior to the first dose), uncontrolled diabetes, uncontrolled hypertension (systolic blood pressure =150 mmHg and/or diastolic blood pressure =100 mmHg despite treatment), active gastrointestinal ulcers, or active bleeding. 16.Presence of pleural effusion, pericardial effusion, or symptomatic ascites that cannot be co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR(objective response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR(disease control rate);PFS(Progression Free Survival);OS(Overall Survival);PK(pharmacokinetics);ADA(Anti-drug antibody); | — |
Countries
China
Contacts
Public ContactLiang Tingbo
The first affiliated hospital, Zhejiang University School of Medicine
Outcome results
None listed