Advanced solid tumor
Conditions
Interventions
Experimental group:ABP1019A Tablet
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Voluntarily sign an informed consent form and comply with the requirements of the plan; (2) 18 years old = age = 65 years old, no gender limit; (3) Expected survival time = 12 weeks; (4) ECOG = 1 point (for patients with solid tumors other than gliomas), or KPS = 60 point (for patients with gliomas); (5) Phase I study: Patients with advanced solid tumors who still experience disease progression under standard treatment, are intolerant to standard treatment, or lack effective standard treatment, and are confirmed by pathology or cytology; At least one measurable lesion that meets the criteria for evaluating the efficacy of solid tumors (RECIST) v1.1; Phase II study: patients with glioma, pancreatic cancer, gastric cancer, ovarian cancer, bladder epithelial cancer or other sensitive tumors found in phase I test who failed or could not tolerate standard treatment and were confirmed by pathology or cytology; At least one measurable lesion that meets the RECIST v1.1 standard (there is at least one intracranial measurable tumor lesion in gliomas according to the RANO standard); (6) Prior to the first administration, the patient had already recovered from the toxic effects of previous treatments (CTCAE = 1 level, except for special cases such as hair loss and pigmentation). In addition, the researcher determined that the corresponding AE did not pose a safety risk; (7) Systolic blood pressure = 140 mmHg, diastolic blood pressure = 90 mmHg, and there is no change in the antihypertensive medication and dosage used within 7 days before the first administration. (8) Organ and bone marrow functional levels must meet the following requirements: Bone marrow: Absolute neutrophil count (ANC) = 1.5 × 10^9/L, platelet count = 100 × 10^9/L, hemoglobin = 90 g/L, and no platelet or red blood cell transfusion within 14 days before the first administration, and no blood transfusion or biological response regulator treatment (such as granulocyte growth factor, erythropoietin, interleukin-11, etc.) has been received within 14 days before the first administration; Liver function: No history of cirrhosis (decompensated cirrhosis Child Pugh B, C grade). Patients without liver metastasis require serum total bilirubin (TBIL) = 1.5 × Upper limit of normal (ULN) (excluding unconjugated hyperbilirubinemia or Gilbert syndrome), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 × ULN. Patients with liver metastasis require TBIL = 2.5 × ULN, ALT, and AST = 5 × ULN; Renal function: serum creatinine = 1.5 × ULN, or creatinine clearance rate>50 mL/min (Cockcorft Gault formula); Qualitative analysis of urine protein = 1+; If the qualitative urine protein is = 2+, a 24-hour urine protein quantitative test is required, and the protein content in the urine within 24 hours is less than 1g; Researchers make inclusion judgments based on the examination results; Coagulation function: prothrombin time (PT) = 1.5 times ULN, international standardized ratio (INR) = 1.5 × ULN, with activated partial thromboplastin time (APTT) = 1.5 × ULN. Female participants of childbearing age must undergo a serum pregnancy test within 3 days before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive measure (such as an intrauterine device, contraceptive pill, or condom) during the study period and within 6 months after the last administration of the study medication; For male participants wh
Exclusion criteria
Exclusion criteria: (1) Previous or current malignant tumors of other types, except for the following: a) Radically treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical cancer in situ; b) Second primary cancers that have been eradicated and have not recurred within five years; (2) Patients who are allergic to any component of the study drug or have a previous history of severe allergy; (3) Received any of the following treatments or medications prior to the first study treatment: a) Major surgery or severe trauma within 4 weeks prior to the first study drug treatment (major surgery is defined as any invasive procedure in which extensive resection is performed or in which the mesothelial cell barrier (e.g., pleural cavity, peritoneum, meninges) is required to be opened. However, tissue biopsies required for diagnostic purposes are permitted. Severe trauma is defined as the presence of unhealed wounds, ulcers, or fractures; b) Chinese (adult) medicine therapy with an antitumor indication within 2 weeks prior to the first study drug treatment. c) Anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biologic therapy, or tumor embolization) within 4 weeks prior to the first dose of study medication; = 2 weeks of discontinuation in the case of oral fluorouracil analogs and endocrine therapy; = 6 weeks of discontinuation in the case of nitrosoureas, mitomycin, or monoclonal antibodies. If the elution time is not adequate due to scheduling or drug PK properties, this needs to be discussed with the sponsor ;-) d) Received a drug known to significantly prolong the QT interval (e.g., class Ia and class III antiarrhythmics) within 1 week prior to the first dose; (4) Patients with a history of CNS metastases (non-tumor meningeal metastases in patients) or spinal cord compression may be enrolled in the study if definitively treated, clinically stable, asymptomatic, and clinically stable after discontinuing anticonvulsants and steroids for 4 weeks prior to the first dose of the study; (5) Patients with symptomatic, advanced disease that has disseminated to the viscera and is at risk of life-threatening complications in the short term, and patients with pleural effusions, peritoneal effusions, and pericardial effusions who have had a puncture and drainage within three weeks prior to the first dose of study drug; (6) Imaging evidence of major vascular infiltration (e.g., pulmonary artery, superior vena cava, or inferior vena cava), significant tumor invasion into the esophagus or organs adjacent to the gastrointestinal tract lesion (large arteries or trachea or gastrointestinal tract) resulting in a high risk for hemorrhage or fistulae; and patients with post-tracheal endoluminal stenting. (7) Cardiovascular disease meeting any of the following criteria in the 6 months prior to screening: a) Congestive heart failure with cardiac function = New York Heart Association (NYHA) class II; left ventricular ejection fraction (LVEF) 450 ms in men and >470 ms in women, or the presence of risk factors for tip-twisting ventricular tachycardia, such as hypokalemia judged by the investigator to be clinically significant, a history of familial long QT syndrome, or a history of familial arrhythmias (e.g., pre-excitation syndrome); d) Unstable angina, myocard
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose restriction toxicity (DLT);Maximum tolerated dose (MTD);Adverse events (AE), serious adverse events (SAE),Lab tests, vital signs;Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of single / multiple administration of ABP1019A tablet;QTcF;Objective response rate (ORR),disease control rate (DCR),duration of response (DOR),Progression-free survival (PFS),6-month progression free survival, sustained response rate, and overall survival within 2 years.;Adverse events (AE), serious adverse events (SAE),Lab tests, vital signs;disease control rate (DCR),duration of response (DOR),Progression-free survival (PFS),6-month progression free survival, sustained response rate, and overall survival within 2 years.; | — |
Countries
China
Contacts
Public ContactShi Yuankai
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed