Advanced solid tumors (including osteosarcoma, etc.)
Conditions
Interventions
Test group:ABP1011T Tablet
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form and comply with protocol requirements; 2. Age 18 years =12 weeks; 4. ECOG performance status = 1.5 × 10?/L, platelet count >= 75 × 10?/L, hemoglobin >= 90 g/L, with no transfusion of platelets or red blood cells within 14 days prior to the first dose, and no transfusion or treatment with biological response modifiers (e.g., granulocyte colony-stimulating factor, erythropoietin, interleukin-11) within 14 days prior to the first dose; Liver function: No history of liver cirrhosis (decompensated cirrhosis Child-Pugh B or C). For patients without liver metastases: serum total bilirubin (TBIL) 50 mL/min (Cockcroft-Gault formula); Urine protein qualitative = 2+, 24-hour urine protein quantification is required. The investigator will determine eligibility based on test results. Coagulation function: Prothrombin time (PT) <= 1.5 × ULN; International Normalized Ratio (INR) <= 1.5 × ULN, and activated partial thromboplastin time (APTT) <= 1.5 × ULN. 10. Female subjects of childbearing potential must undergo a serum pregnancy test within 3 days prior to initiating study medication, with negative results, and must agree to use a medically approved highly effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study period and for 6 months after the last study dose. Male subjects with female partners of childbearing potential must agree to use effective contraception during the study period and for 6 months after the last study dose.
Exclusion criteria
Exclusion criteria: 1. History of or current presence of other malignant tumors, except for the following: a) Completely resected basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ; b) Completely resected secondary primary cancer with no recurrence within five years; 2. Patients with known hypersensitivity to any component of the study drug or similar agents, or with a history of severe allergic reactions; 3. Received any of the following treatments or medications prior to the first study treatment: a) Major surgery or severe trauma within 4 weeks before the first study drug administration (Major surgery is defined as any invasive procedure involving extensive excision or breaching of the mesothelial barrier, e.g., pleural cavity, peritoneum, meninges. However, diagnostic tissue biopsies are permitted). Severe trauma refers to unhealed wounds, ulcers, or fractures; b) Received Chinese herbal medicine or traditional Chinese medicine for antitumor indications within 2 weeks prior to the first study drug dose. c) Received antitumor therapy (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biologic therapy, or tumor embolization) within 4 weeks prior to the first study drug dose; For oral fluoropyrimidine drugs and endocrine therapy, discontinuation =4 weeks prior to the first study dose, and the investigator determines that the subject's benefit outweighs the risk, the subject may be considered for screening and enrollment); If asymptomatic, or if anticonvulsants and steroids were discontinued for 4 weeks prior to the first study dose with stable clinical presentation following confirmed treatment, enrollment may proceed. 5. Patients with symptomatic disease, visceral spread, or imminent risk of life-threatening complications in advanced disease; patients with pleural effusion, ascites, or pericardial effusion who underwent paracentesis or thoracentesis within 3 weeks prior to the first study dose. 6. Imaging evidence of tumor encasement or infiltration of major vessels (e.g., pulmonary artery, pulmonary vein, superior vena cava, inferior vena cava), significant tumor invasion into adjacent organs (aorta, trachea, or gastrointestinal tract) adjacent to esophageal or gastrointestinal lesions posing high bleeding or fistula risk; and patients who have undergone tracheal stent placement. 7. Presence of cardiovascular disease meeting any of the following criteria within 6 months prior to screening: a) Congestive heart failure with cardiac function = New York Heart Associat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Duration of Relief (DOR);Disease Control Rate (DCR);4-month progression-free survival rate;Sustained response rate;Overall Survival (OS) ;Two-year overall survival rate;Safety indicators; | — |
Countries
China
Contacts
Public ContactXiaodong Tang
Peking University People's Hospital
Outcome results
None listed